RCHR (Republican Center for Health Development of the Ministry of Health of the Republic of Kazakhstan)
Version: Clinical protocols of the Ministry of Health of the Republic of Kazakhstan - 2013

Uterine leiomyoma, unspecified (D25.9)

Obstetrics and gynecology

General information

Brief description

Approved by the Minutes of the meeting of the Expert Commission
on health development issues of the Ministry of Health of the Republic of Kazakhstan
No. 23 dated December 12, 2013

Uterine fibroids(leiomyoma - histological diagnosis) - a benign tumor of the smooth muscle fibers of the uterus (1).

I. INTRODUCTORY PART

Protocol name: Uterine fibroids (uterine leiomyoma)
Protocol code: O

ICD-10 code(s):
D25 Leiomyoma of the uterus
D25.0 Submucosal leiomyoma of the uterus
D25.1 Intramural uterine leiomyoma
D25.2 Subserous leiomyoma of the uterus
D25.9 Uterine leiomyoma, unspecified

Date of development of the protocol: April 20, 2013

Abbreviations used in the protocol:
MRI - magnetic resonance imaging,
MC - menstrual cycle,
AH - abdominal hysterectomy,
VG - vaginal hysteectomy,
LAVH - vaginal hysterectomy with laparoscopic assistance,
OVIS - ovarian wasting syndrome.

Protocol users: obstetrician-gynecologist, gynecological oncologist

Classification

Clinical classification (1,2):

1. By localization and direction of growth:
- Subperitoneal (subserous) - growth of a myomatous node under the serous membrane of the uterus towards the abdominal cavity (intra-abdominal location, intraligamentous location).
- Submucosal (submucosal) - the growth of a myomatous node under the mucous membrane of the uterus towards the organ cavity (in the uterine cavity, birth, birth).
- Intrawall (interstitial) - growth of a node in the thickness of the muscular layer of the uterus (in the body of the uterus, in the cervix).

2. According to clinical manifestations:
- Asymptomatic uterine fibroids (70-80% of cases).
- Symptomatic uterine fibroids (20-30% of cases) - clinical manifestations of symptomatic uterine fibroids (menstrual cycle disorders such as menometrorrhagia, dysmenorrhea; pain syndrome of varying severity and nature (pulling, cramping); signs of compression and/or dysfunction of the pelvic organs; infertility; recurrent miscarriage; secondary anemia).

Diagnostics

II. METHODS, APPROACHES AND PROCEDURES FOR DIAGNOSIS AND TREATMENT

List of basic and additional diagnostic measures:

1. Complaints: menorrhagia (hyperpolymenorrhea, metrorrhagia, pain, anemia (III, 3,4).

2. Physical examination:
- bimanual examination: the uterus is enlarged in size, nodes are determined, the uterus and nodes are dense (III, 3,4).

3. Laboratory research: decrease in hemoglobin (anemia of varying severity) in the absence of extragenital pathology.

4. Instrumental research:
- Ultrasound examination of the pelvic organs with vaginal and abdominal sensors: size, quantity, location, echogenicity, structure of nodes, presence of concomitant endometrial hyperplasia, ovarian pathology (III, 5).

In doubtful cases, for the purpose of differential diagnosis with ovarian tumors, an MRI of the pelvis is performed (III, 5).

Hysteroscopy is performed to identify submucosal myomatous nodes and endometrial pathology (III, 6).

Diagnostic laparoscopy is performed if differential diagnosis is necessary (leiomyoma or ovarian tumors) (III).

Dopplerography to recognize secondary changes in the myometrium, features of vascularization of nodes (5).

At the prehospital level, the following examination methods are carried out:
- investigation of complaints,
- vaginal examination,
- determination of hemoglobin,
- Ultrasound of the pelvic organs,
- MRI of the pelvis,
- Dopplerography of nodes and organs of the pelvis (uterus).

Diagnostic criteria

Complaints and anamnesis
In most women, uterine fibroids are asymptomatic, but 20-30% of patients have complaints that are clinical manifestations of complications of fibroids:
- pelvic pain, heaviness in the lower abdomen;
- if complications such as necrosis of the node, infarction, torsion of the node’s legs occur, a picture of an “acute abdomen” may develop. There may be sharp pain in the lower abdomen and lower back, signs of peritoneal irritation (vomiting, dysfunction of the bladder and rectum), leukocytosis, accelerated ESR, increased body temperature;
- increased frequency of urination;
- other symptoms of compression of adjacent organs: compression of surrounding tissues by a fibroid node that grows, contributes to the occurrence of circulatory disorders with varicose veins, thrombosis of tumor vessels, edema, hemorrhagic infarctions, tumor necrosis, which are manifested by constantly severe pain, sometimes high body temperature;
- with subserous localization of fibroids, depending on their location, dysfunction of adjacent organs (bladder, ureters, rectum) may occur;
- with an increase in tumor size over 14 weeks of pregnancy, the development of myelopathic and radiculalgic syndromes is possible: in the case of the myelopathic variant, which is the result of spinal ischemia, patients complain of weakness and heaviness in the legs, paresthesia, which begins 10-15 minutes after the start of walking and disappears after a short rest; with radiculalgia syndrome, which develops due to compression of the pelvic plexuses or individual nerves by the uterus, women experience pain in the lumbosacral region and lower extremities, and sensitivity disorders in the form of paresthesia.
- uterine bleeding is one of the most common complications. Uterine bleeding contributes to the development of anemia.

Physical examination
Vaginal examination:
- the uterus is enlarged in size,
- nodes are determined,
- the uterus and nodes are dense (III, 3,4).

Laboratory research:
- decrease in hemoglobin (anemia of varying severity) in the absence of extragenital pathology.

Instrumental studies:
- Ultrasound with abdominal and vaginal sensors.
- Ultrasound of the thyroid gland.
- MRI of the pelvis, laparoscopy, hysteroscopy, Doppler ultrasound of the uterus.

In women with an uncertain diagnosis of fibroids after transvaginal ultrasound and transvaginal sonohysterography, or who refuse transvaginal ultrasonography due to possible discomfort, MRI may be recommended (C).

For women diagnosed with uterine fibroids, it is advisable to determine the condition of the thyroid gland, since in 74% of patients, uterine fibroids develop against the background of thyroid pathology (C).

For leiomyomas larger than 12 weeks, it is preferable to perform a transabdominal ultrasound (C).

The transvaginal echography method is highly informative for diagnosing endometrial hyperplasia, however, with this research method it is often not possible to determine submucous uterine fibroids and endometrial polyps (A).

The use of transvaginal echography and transvaginal sonohysterography has greater diagnostic value in determining the localization of submucosal nodes compared to hysteroscopy (A). Preliminary transvaginal sonohysterography in women with intrauterine pathology allows avoiding hysteroscopy in 40% of cases (A).

When performing hysteroscopy, the following recommendations should be used:
- it is more appropriate to use saline solution (A);
- the procedure is performed under anesthesia (A).

Women with asymptomatic fibroids up to 12 weeks in size in the absence of other pathological formations of the pelvic organs require further in-depth examination to identify other pathologies that may be associated with the development of uterine fibroids, and accordingly, it is necessary to treat it. They should see a doctor once a year, or more often if symptoms occur (C).

Women with asymptomatic fibroids for more than 12 weeks should consult with specialists individually in an agreed monitoring regime, but at least once a year, and receive conservative therapy (C) if surgery is refused or if there are contraindications to it. Even in the absence of clinical manifestations of the disease, due to the unfavorable prognosis for fibroids larger than 12 weeks, despite the inhibitory effect of hormone therapy for large fibroids, conservative myomectomy is recommended for women interested in preserving reproductive function (C).

Indications for consultation with specialists:
- Consultation with a gynecological oncologist if endometrial hyperplastic processes or uterine sarcoma are suspected.
- Consultation with a therapist for anemia to determine conservative treatment.

Differential diagnosis

Differential diagnosis: carried out with adenomyosis, ovarian tumors.
Instrumental research methods are used (MRI, hysteroscopy, laparoscopy).

Treatment abroad

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Treatment

Treatment goals:
- elimination of symptoms of the disease,
- reduction in the size of nodes.

Treatment tactics

Non-drug treatment: doesn't exist

Drug treatment

Indications for conservative treatment of uterine fibroids:
1. The patient’s desire to maintain reproductive function.
2. Clinically asymptomatic course of the disease.
3. Uterine fibroids that do not exceed the size of 12 weeks of pregnancy.
4. Interstitial or subserous (wide-based) location of the node.
5. Myoma, accompanied by extragenital diseases with high anesthetic and surgical risk.
6. Conservative treatment as a preparatory stage for surgery or as rehabilitation therapy in the postoperative period after conservative myomectomy.

Drug therapy is the method of choice in women who are not eligible for surgical treatment or who refuse it. It is worth noting that fibroids return to their previous size within 6 months after stopping therapy (C).

Drug treatment includes non-hormonal agents and hormonal therapy drugs.
Non-hormonal agents - predominantly symptomatic therapy: hemostatics (for bleeding) and antispasmodics, non-steroidal anti-inflammatory drugs (for pain), as well as measures aimed at treating pathological conditions that can contribute to the growth of uterine fibroids (thyroid pathology, inflammatory processes of the genitals) and normalization of metabolism substances (antioxidants, antiplatelet agents, multivitamins, herbal medicine) (C).

Hormone therapy- the basis of drug treatment of fibroids, is corrective hormonal therapy aimed at reducing both systemic and local dyshormonemia (C).

Oral contraceptives lead to a reduction in fibroid size, can reduce menstrual blood loss with a significant increase in hematocrit and other hemogram parameters, and can be used for hemostasis (B).

Progestogens are used in the complex of drug treatment of fibroids, which are accompanied by hyperplastic processes of the endometrium in order to reduce local hyperestrogenemia. Drugs, doses and regimens are used that provide stromal suppression of the endometrium (dydrogesterone 20-30 mg from days 5 to 25 of the menstrual cycle (MC)), norethisterone (10 mg from days 5 to 25 of the MC) and linestrol (20 mg from days 5 to 25 of the MC) (IN).

Treatment with GnRH agonists effectively reduces the size of the nodes and uterus, but is used for no more than 6 months due to the development of drug-induced menopause syndrome with long-term use (A). For women with fibroids and endometrial hyperplastic processes, it is recommended to use Gn-RH (goserelin) together with the prescription of dydrogesterone 20 mg from days 5 to 25 (during the first cycle) (C).
Treatment with GnRH agonists (goserelin) in combination with HRT ("add-back" therapy with estrogens and progestins) leads to a reduction in the size of fibroids, does not cause manifestations of drug-induced menopause, and is an alternative treatment method for women who have contraindications to surgical treatment or are informed refusal of surgery (B).

Women diagnosed with fibroids who have spotting when using HRT are advised to reduce the dose of estrogen or increase the dose of progesterone (C).

Observations regarding the confirmation of reduction in fibroid size with the use of progestogen-releasing IUDs are insufficient, however, the positive dynamics of clinical manifestations allows us to recommend this method in the treatment of uterine fibroids (C).

	Level of reliability and effectiveness	Stopping symptoms	Reducing the size of nodes	Maximum duration of use	Possible side effects
COC (for uterine bleeding)	IN	Positive effect	No effect	Not limited in the absence of contraindications from extragenital diseases	Nausea, headache, mastalgia
Gn-Rg analogues (triptorelin 3.75 mg once every 28 days)	A	Positive effect	Positive effect	6 months	Symptoms of drug-induced menopause
Levonorgestrel IUD	IN	Positive effect	Impact not proven	5 years	Irregular spotting, expulsion
Progestogens with a pronounced effect on the endometrium (with concomitant endometrial hyperplasia)	IN	Positive effect	Impact not proven	6 months	Nausea, headache, mastalgia
Danazol	A	Little research	Positive effect	6 months	Androgenic side effect

Other types of treatment: does not exist.

Surgical treatment
The decision to perform a hysterectomy or myomectomy is made depending on: the woman’s age, the course of the disease, the desire to preserve reproductive potential, the location and number of nodes (C):

For women with a large uterus (more than 18 weeks) or anemia, it is recommended to prescribe GnRH agonists (goserelin, triptorelin) for 2 months before surgical treatment (B) in the absence of a gynecological oncological history.
- Women diagnosed with submucosal fibroids and significant bleeding also undergo hysteroscopic myomectomy, endometrial ablation, or endometrial resection as an alternative to hysterectomy (B).
- For women under 45 years of age with subserous or intramural symptomatic fibroids who are interested in preserving the uterus as an alternative to hysterectomy, myomectomy (C) is recommended with mandatory intraoperative histological rapid examination of the removed node.

Laparoscopic myomectomy is not suitable for women planning pregnancy due to evidence of an increased risk of uterine rupture (C).

There is insufficient data on the effectiveness of using oxytocin, vasopressin during surgery to reduce blood loss (B).

There are insufficient data to evaluate the effectiveness of laser-inductive interstitial thermotherapy, myolysis, or cryomyolysis (C).

Fibroid embolization may be an effective alternative to myomectomy or hysterectomy (C).

Surgical treatment of accidentally discovered asymptomatic fibroids in order to prevent its malignancy is not recommended (C).

Combination therapy for fibroids
It consists of the use of surgical treatment in the amount of conservative myomectomy against the background of drug therapy (use of Gn-RH analogues in the pre- and postoperative period).

Indications for combination therapy(use of agonists and leiomyomectomy):
1. A woman’s interest in preserving the uterus and reproductive function.
2. Myoma with a large number of nodes.
3. Myoma with a node larger than 5 cm.

Stages of combination therapy:
Stage I - 2 injections of AGN-RG with an interval of 28 days.
Stage II - conservative myomectomy.
Stage III - third injection of AGN-RG.

Indications for myomectomy as stage II of combined treatment:
1. Lack of dynamics of reduction in the size of the myomatous node after 2 injections of Gn-RH analogues. Considering the literature data on the high risk of malignancy of AGN-RH resistant nodes, it is considered advisable to perform urgent surgical intervention.
2. Preservation of clinical symptoms (pain, dysfunction of adjacent organs, etc.) even with positive dynamics in the size of the node.

Advantages of performing surgical interventions against the background of AGN-RG prescription:
- reduction in the size of nodes, vascularization and blood loss;
- reduction of operation time;
- reducing the time for normalization of the functional mass and size of the uterus after conservative myomectomy.

Indications for surgical treatment of fibroids:
1. Symptomatic fibroids (with hemorrhagic and pain syndrome, the presence of anemia, symptoms of compression of adjacent organs).
2. The size of fibroids is 13-14 weeks or more.
3. Presence of a submucosal node.
4. Suspicion of a power failure of the node.
5. The presence of a subserous fibroid node on a stalk (due to the possibility of torsion of the node).
6. Rapid growth (4-5 weeks per year or more) or resistance to therapy with GnRH analogues).
7. Myoma in combination with precancerous pathology of the endometrium or ovaries.
8. Infertility due to uterine fibroids.
9. Presence of concomitant pathology of the pelvic organs.

Principles for choosing a hysterectomy approach:
1. There are clear indications and contraindications for both abdominal (AH) and vaginal hysterectomy (VH).
2. In some cases, laparoscopically assisted VG (LAVG) is indicated
3. If hysterectomy can be performed by any approach, then in the interests of the patient, the advantage is determined in the following order: VH> LAVH> AG.

Indications and conditions for performing VG:
- Absence of concomitant pathology of applications;
- Sufficient mobility of the uterus;
- Sufficient surgical access;
- Size of the uterus up to 12 weeks;
- Experienced surgeon.

Contraindications to VG:
- The size of the uterus is more than 12 weeks;
- Limited mobility of the uterus;
- Concomitant pathology of the ovaries and fallopian tubes;
- Insufficient surgical access;
- Cervical hypertrophy;
- Inaccessibility of the cervix;
- History of surgery for vesicovaginal fistula;
- Invasive cervical cancer.

Conditions in which the use of AG is advantageous:
- There are contraindications to VH, LAVG is difficult or risky;
- Mandatory oophorectomy, which cannot be performed in any other way;
- Adhesive process, due to concomitant endometriosis and inflammatory diseases of the pelvic organs;
- Rapid tumor growth (suspicion of malignancy);
- Suspicion of malignancy of a concomitant ovarian tumor;
- Myoma of the broad ligament;
- Doubts about the benignity of the endometrium;
- Concomitant extragenital pathology.

Indications for subtotal hysterectomy (supravaginal amputation of the uterus):
1. In cases where the patient insists on preserving the cervix, in the absence of pathology of the epithelium of the vaginal part and endocervix.
2. Severe extragenital pathology, requiring a reduction in the duration of the operation.
3. Severe adhesions or pelvic endometriosis, due to an increased risk of injury to the sigmoid colon or ureter or other complications.
4. The need for urgent hysterectomy in exceptional cases (the absence of the cervical removal stage reduces the duration of the operation and is essential when performing urgent surgery).

Scope of surgery in relation to the uterine appendages is based on the principles:

The following arguments are in favor of prophylactic oophorectomy:
- First, in 1-5% of cases there is a need for repeated surgery for benign ovarian tumors.
- Second, ovarian function after a hysterectomy deteriorates somewhat and after two years, most women develop ovarian wasting syndrome.

The following arguments speak against prophylactic oophorectomy:
- First, there is a high risk of developing surgical menopause syndrome after removal of the ovaries, an increase in mortality from osteoporosis and cardiovascular diseases, which in most cases require long-term use of HRT.
- The second is the psychological aspects associated with the removal of the ovaries.

Embolization is a promising method for the treatment of symptomatic uterine fibroids - both as an independent method and as a preoperative preparation for subsequent myomectomy, which can reduce the amount of intraoperative blood loss.

Advantages of vascular embolization:
- Less blood loss;
- Low incidence of infectious complications;
- Low mortality rate;
- Reducing recovery time;
- Fertility preservation.

Possible complications of embolization:
- Thromboembolic complications;
- Inflammatory processes;
- Necrosis of the subserous node;
- Amenorrhea.

Indications for different types of hysterectomy depending on the clinical situation

Indications/situationsI	Access
	vaginal	tentative	LAVG	abdominal
Uterine bleeding	A
Adenomyosis	A
Leiomyoma: uterus up to 12 weeks	A
Leiomyoma: uterus 13-16 weeks			B1	A
Leiomyoma: uterus 17-24 weeks			B1	A
Leiomyoma: uterus > 22-24 weeks				A
Endometrial hyperplasia	A
Recurrent polyp of the cervical canal or endometrium	A
Associated mental disorders	A			B1
Cervical intraepithelial neoplasia	A
Malignant process of the endometrium	B2		B1	A
Benign pathology of the uterine appendages with good mobility			A	B1
Benign pathology of the uterine appendages with pronounced adhesions			B1	A

Notes: A is the first choice method, B1 is the first alternative method, B2 is the second alternative method.

Preventive measures: With There is no specific prevention.

Further management
After hysterectomy, depending on the extent of the operation:
- After subtotal hysterectomy - with appendages, monophasic estrogen-gestagen drugs are recommended; without appendages - prevention of SIJ.
- After a total hysterectomy - with appendages, HRT with estrogen is recommended, without appendages - prevention of SIH.

Indicators of treatment effectiveness:
- induction of remission,
- relief of complications.

Hospitalization

Indications for hospitalization:

Planned hospitalization for surgical treatment.

Emergency hospitalization at:
- uterine bleeding,
- clinic of acute abdomen (necrosis of the node, torsion of the leg of the node),
- severe pain syndrome (cramping pain in the lower abdomen with nascent uterine fibroids).

Information

Sources and literature

1. Minutes of meetings of the Expert Commission on Health Development of the Ministry of Health of the Republic of Kazakhstan, 2013
   1. 1. Clinical lectures on obstetrics and gynecology edited by Kayupova N.A., volume II 2000 2. Gynecology. National leadership / ed. E.K. Ailamazyan, V.I. Kulakov, V.E. Radzinsky, G.M. Savelyeva. – M.: GEOTAR-Media, 2007. 3. American College of Obstetricians and Gynecologists (ACOG). Surgical alternatives tohysterectomy in the management of leiomyomas. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2000 May. 10 p.m. (ACOG practice bulletin; no. 16). 4. Gynaecological tumors EBM Guidelines. 12.8.2005 5. Clinical recommendations based on evidence-based medicine: Transl. from English /Ed. Yu.L. Shevchenko, I.N. Denisova, V.I. Kulakova, R.M. Khaitova. - 2nd ed., revised - M.: GEOTAR-MED, 2002. -1248 p.: ill. 6. Evidence-based medicine. Annual Quick Guide. Publishing house "MediaSphere", issue No. 3. - 2004.

Information

III. ORGANIZATIONAL ASPECTS OF PROTOCOL IMPLEMENTATION

Evaluation criteria for monitoring and auditing the effectiveness of protocol implementation.
1. Number of surgical interventions for uterine fibroids
2. Number of complications
3. Types of surgery

List of protocol developers:
Doshchanova A.M. - Doctor of Medical Sciences, professor, doctor of the highest category, head of the department of obstetrics and gynecology for internship at JSC "MUA".

Reviewers:
doctor of the highest category, doctor of medical sciences, professor Ryzhkova S.N.

Disclosure of no conflict of interest: No.

Indication of the conditions for reviewing the protocol: when new proven data becomes available.

IV. Application

1. Diagnostic investigations

№	Basic diagnostic tests	Frequency of application	Likelihood of application
1	Bimanual examination	1 time	100%
2	General blood test	1 time	100%
3	Ultrasound with abdominal, vaginal sensor	1 time	100%
№	Additional diagnostic tests	Frequency of application	Likelihood of application
1	Ultrasound of the thyroid gland	1 time	33%
2	MRI of the pelvis	1 time	33%
3	Laparoscopy	1 time	10%
4	Hysteroscopy	1 time	10%
5	Doppler ultrasound of the uterus	1 time	70%

2. Medical products and medicines

№	Basic	Quantity per day	Duration of use	Likelihood of application
1	Hormonal therapy: Estrogen-progestin drugs	1 tablet per day	6 months	33%
2	Analogs of Gn-Rg (triptorelin)	3.75 mg 1 time on day 28	6 months	33%
3	Danazol	400mg per day	6 months	33%
№	Additional	Quantity per day	Duration of use	Likelihood of application
	IUD with levonorgestrel	1 time	5 years	33%
2	Progestins (COC-dydrogesterone, Norethisterone,	20-30 mg from 5 to 25 days of MC 10 mg from 5 to 25 days of MC	6 months	33%

Attached files

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RCHR (Republican Center for Health Development of the Ministry of Health of the Republic of Kazakhstan)
Version: Clinical protocols of the Ministry of Health of the Republic of Kazakhstan - 2016

Uterine leiomyoma (D25)

Obstetrics and gynecology

General information

Brief description

Approved
Joint Commission on Health Care Quality
Ministry of Health and Social Development
dated June 9, 2016

Uterine fibroids (leiomyoma)- monoclonal benign tumor of the smooth muscle fibers of the uterus.

Correlation of ICD-10 and ICD-9 codes

ICD-10 codes

ICD-9 codes

D25 Leiomyoma of the uterus D25.0 Submucosal leiomyoma of the uterus D25.1 Intramural uterine leiomyoma D25.2 Subserous leiomyoma of the uterus D25.9 Leiomyoma of the uterus, unspecified

39.7944 Endovascular embolization of vessels of the pelvic organs, uterine arteries. 68.4110 Laparoscopic conservative myomectomy or hysteroresection of submucosal nodes. 68.51 Laparoscopic vaginal hysterectomy. 68.411 Laparoscopic total hysterectomy. 67.30 Other types of excision or destruction of the affected area or tissue of the cervix. 67.39 Other methods of excision or destruction of the affected area or tissue of the cervix. 68.31 Laparoscopic supravaginal hysterectomy. 68.41 Laparoscopic total abdominal hysterectomy. 68.29 Other types of excision or destruction of the affected area of ​​the uterus. 68.30 Supravaginal abdominal amputation of the uterus. 68.39 Other and unspecified abdominal hysterectomies. 68.40 Complete abdominal hysterectomy. 68.49 Other and unspecified total abdominal hysterectomies. 68.50 Vaginal hysterectomy. 68.59 Other vaginal hysterectomies. 68.81 Extirpation of the uterus with ligation of the internal iliac arteries. 68.90 Other and unspecified hysterectomy. 69.09 Other types of uterine dilatation and curettage.

Date of development of the protocol: 2013 (revised 2016).

Protocol users: GPs, obstetricians-gynecologists, oncologists.

Level of evidence scale:
The relationship between the strength of evidence and the type of scientific research.

	Level of evidence		Classification of recommendations
I	Evidence from at least one well-randomized controlled trial	A	High level of evidence for the use of clinical preventive actions.
II-1	Evidence from well-designed controlled trials without randomization	IN	Good level of evidence for use of clinical preventive actions
II-2	Data obtained from well-designed cohort studies (prospective or retrospective) or case-control studies, preferably from multiple academic medical centers or study groups	WITH	This evidence is conflicting and does not allow a specific recommendation for or against the use of clinical preventive actions
II-3	Evidence obtained by comparing the number or location of localization with or without intervention. Obvious results in uncontrolled studies (such as the results of penicillin treatment in the 1940s) may also be included in this category	D	Good level of evidence does not recommend the use of clinical preventive actions
III	Opinions of reputable experts based on clinical experience, demonstrative studies or reports of expert committees	E	High level of evidence against the use of clinical preventive actions
		L	Insufficient level of evidence (in quality or quantity) to make a recommendation, but other factors may influence the decision

Classification

By location and direction of growth:
· subperitoneal (subserous) - growth of the myomatous node towards the abdominal cavity under the serous membrane of the uterus;
· submucosal (submucosal) - growth of the myomatous node towards the organ cavity under the mucous membrane of the uterus;
· intramural (interstitial) - growth of a node in the thickness of the muscular layer of the uterus.

According to FIGO(2011) .

According to clinical manifestations:
· asymptomatic uterine fibroids (50-80% of cases) - without clinical manifestations;
· symptomatic uterine fibroids (20-50% of cases) - with clinical manifestations.

Diagnostics (outpatient clinic)

OUTPATIENT DIAGNOSTICS

Diagnostic criteria (LE - III)

Complaints:
· abnormal uterine bleeding;
· pelvic pain;
· heaviness in the lower abdomen;
· abdominal enlargement;
· dysfunction of the bladder (dysuria);
bowel dysfunction (dyschezia)
· infertility.

Anamnesis:
Significant points in the anamnesis are:
· absence of pregnancy and childbirth;
· early menarche,
Increased frequency of menstruation;
Duration of dysmenorrhea;
· burdened heredity;
· increased body weight;
· arterial hypertension;
· diabetes mellitus;
· age (peak incidence 40-50 years).

Physical examination:
Bimanual vaginal examination:
· the uterus is enlarged in size, with uneven contours due to dense nodes.

Laboratory research:
· UAC - decrease in hemoglobin (anemia of varying severity) in the absence of extragenital pathology.

Instrumental studies:

· Ultrasound (transvaginal, transabdominal, transvaginal sonohysterography with contrast):
− sensitivity and specificity 98-100%. (UD - A);
− small heterogeneous echoes within the boundaries of the myometrium;
− hypoechoic and heterogeneous echostructure of the uterus with uneven contours;
− a sign of malnutrition of the myomatous node is the presence of cystic areas within the fibroids.

NB! when the size of uterine fibroids is more than 12 weeks, it is preferable to perform a transabdominal ultrasound (UD - C).

NB! Transvaginal sonohysterography with contrast (injection of saline into the uterine cavity) has a high diagnostic value for submucosal nodes and allows differentiation from endometrial polyps.

NB! submucous uterine fibroids have less echogenicity than polyps and the surrounding endometrium, and careful examination allows us to visualize its “continuation” in the surrounding myometrium.

· MRI - in the presence of atypical forms of formations of the pelvis and abdominal cavity. (UD - C).

Diagnostic algorithm:

Diagnostics (ambulance)

DIAGNOSTICS AT THE EMERGENCY CARE STAGE

Diagnostic measures:

Complaints:
· bloody discharge from the genital tract, pain in the lower abdomen.

Physical examination:
· pallor of the skin and visible mucous membranes;
· decreased blood pressure, tachycardia.

Examination and palpation of the abdomen:
· gentle position of women;
Pain on palpation of the lower abdomen;
· positive symptoms of peritoneal irritation with torsion of the node leg and necrosis of the node.

Diagnostics (hospital)

DIAGNOSTICS AT THE INPATIENT LEVEL

Diagnostic criteria at the hospital level: see diagnostic criteria at outpatient level.

Diagnostic algorithm:

List of main diagnostic measures:
· UAC.

List of additional diagnostic measures:
· Ultrasound of the pelvis transvaginally and/or abdominally,
· hysterosonography of the small pelvis;
· hysteroscopy;
· MRI of the pelvis.

NB! In a hospital setting, all types of therapeutic and diagnostic measures can be carried out if the indications are justified and take into account the existing underlying and concomitant diseases within the framework of existing clinical protocols.

Differential diagnosis

Differential diagnosis and rationale for additional studies

Diagnosis	Rationale for differential diagnosis	Survey	Diagnosis exclusion criteria
Adenomyosis	Same clinical picture	Ultrasound, MRI Histological examination	Characteristic is the absence of blood flow in the CDK mode with adenomyosis, thickening of the transition zone of the endometrium;
Uterine cancer/uterine sarcoma	No specific symptoms	History, ultrasound, MRI	Rapid tumor growth, atypical sonographic picture and MRI, such as unclear boundaries and invasion into adjacent organs
Endometrial polyp	No specific symptoms	Ultrasound, MRI	Well-defined polypoid formation with a structure similar to the endometrium.

Treatment abroad

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Treatment

Drugs (active ingredients) used in treatment

Ascorbic acid

Gestodene

Danazol

Desogestrel

Dextrose

Dienogest

Ferric sulfate

Ibuprofen

Potassium chloride (Potassium chloride)

Calcium chloride

Naproxen

Sodium acetate

Sodium acetate trihydrate

Sodium bicarbonate

Sodium chloride

Tranexamic acid

Ulipristal

Ethinylestradiol

Treatment (outpatient clinic)

OUTPATIENT TREATMENT

Treatment tactics

Treatment of women with fibroids/leiomyomas should be individualized based on symptoms, size and location of fibroids, age, patient wishes, need to preserve fertility or uterus, availability of therapy, and physician experience (LE-IIIB).

Non-drug treatment: No.

Drug treatment:

Indications for drug therapy for uterine fibroids:
· the patient’s desire to maintain reproductive function;
· uterine fibroids that do not exceed the size of 12 weeks of pregnancy;
· fibroids accompanied by extragenital diseases with high anesthetic and surgical risk;
· drug therapy as a preparatory stage for surgery or as rehabilitation therapy in the postoperative period after conservative myomectomy.

Effective treatment for women with abnormal uterine bleeding caused by fibroids includes: levonorgestrel-containing intrauterine systems (UD - I) GnRH analogues, (UD-I) selective progesterone receptor modulators, (UD - I) oral contraceptives, (UD - II-2 ) progestins, (UD - II-2) and danazol (UD - II2).

NB! Effective treatments for symptomatic uterine fibroids are selective progestin receptor modulators and gonadotropin-releasing hormone analogues. (UD - I).

NB! Treatment with GnRH a is effective in reducing the size of nodes and uterine bleeding, but is used for no more than 6 months due to the development of drug-induced menopause syndrome with long-term use (LE - A).

NB! Ulipristal acetate effectively stops uterine bleeding, reduces the volume of uterine fibroids and increases the time of preoperative preparation of patients, which is important in the presence of anemia in patients and/or the presence of concomitant extragenital pathology (UD - A).

NB! OC and IUD-LNG are effective against uterine bleeding, but are ineffective in reducing the volume of myomatous nodes.

NB! Danazol - reduces the volume of nodes by 20-25%, effectively reduces the volume of heavy menstrual bleeding, but there is insufficient data on the effectiveness of long-term therapy for fibroids.

NB! Drug therapy is the method of choice in women who are not eligible for surgical treatment or who refuse it. It is worth noting that the size of fibroids returns to their previous size within 6 months after cessation of therapy (LE - C).

List of essential medicines:
ulipristal acetate - 5 mg;
· A-GnRg - 11.25 mg;
· IUD with levonorgestrel - 52 mg;
· Danazol;
· ethinyl estradiol dienogest 2 mg;
· ethinyl estradiol gestodene 75 mg;
· ethinyl estradiol desogestrel 150 mcg.

· NSAIDs;
· iron supplements;
· Trenax.

Algorithm of action in emergency situations at the outpatient level:

Other treatments provided on an outpatient basis: no

Table - 1. Drug comparison table:

Drug name	UD	Termination Symptoms	Reducing the size of the node	Maximum duration of therapy	Possible side effects
Ulipristal acetate	A	+	+	4 courses for 3 months	Headache, nausea, mood changes, PAEC
A-GnRg	A	+	+	6 months	Symptoms of drug-induced menopause
IUD with LNG	IN	+	-	5 years	Irregular spotting, expulsion
COOK	IN	+	-	Unlimited if there are no contraindications from the EGP
Danazol	A	Little research	+	6 months	Androgenic side effect
Progestogens with a pronounced effect on the endometrium	IN	+	Impact not proven	6 months	Nausea, headache, mastalgia

· consultation with a gynecological oncologist - if endometrial hyperplastic processes or uterine sarcoma are suspected.
· consultation with a therapist - for anemia, to determine conservative treatment.
· consultations with related specialists in the presence of extragenital diseases.

Preventive measures: No.

Monitoring the patient's condition:
· women with asymptomatic fibroids up to 12 weeks in size in the absence of other pathological formations of the pelvic organs require further in-depth examination to identify other pathologies that may be associated with the development of uterine fibroids, and accordingly, it is necessary to treat it;
· they should consult a doctor once a year, or more often if symptoms of the disease occur (LE - C);
· women with asymptomatic fibroids for more than 12 weeks should consult with specialists individually in an agreed monitoring regime, but at least once a year, and receive conservative therapy (UD-S) in case of refusal of surgery or if there are contraindications to it.

· reduction in the size of uterine fibroids or lack of growth of nodes;
· prevention of relapse of the disease.

Treatment (ambulance)

TREATMENT AT THE EMERGENCY STAGE

Drug treatment provided at the emergency stage:

Crystalloid infusion therapy for massive bleeding:
· sodium chloride solution;
· sodium acetate;
· sodium bicarbonate;
· potassium chloride;
sodium acetate trihydrate,
· potassium chloride;
· Ringer Locke solution;
· glucose solution.
· pain relief for severe pain syndrome:

· ibuprofen 5 mg/2 ml, ampoules; tablet, 5 mg.
Antifibrinolytic therapy - to reduce blood loss:
Trenax tablets 250 mg, 500 mg; 5 ml ampoule.

Treatment (inpatient)

INPATIENT TREATMENT

Treatment tactics

Non-drug treatment: No.

Drug treatment:
· antibacterial prevention of postoperative infectious complications;
· antibiotic therapy in case of emergency hospitalization due to necrosis or torsion of the leg of the node;
· adequate analgesic therapy;
· infusion therapy with crystalloids and colloids according to indications;
· correction of anemia;
· prevention of thromboembolic complications in the postoperative period.

List of essential medicines

Antifibrinolytic drugs:
tranexamic acid tablets 250 mg, 500 mg; 5 ml ampoule.

Iron supplements:
· iron (II) sulfate dry + ascorbic acid tablet 320 mg/60 mg;
· iron (II) sulfate heptahydrate + ascorbic acid syrup, 100 ml, iron sulfate drops, 25 ml, bottles.

Colloidal and crystalloid solutions(in total volume up to 1500-2000 ml):
· sodium chloride solution;
· sodium bicarbonate;
· potassium chloride;
· sodium acetate trihydrate;
· potassium chloride;
· glucose solution.

Analgesics:
Naproxen tablets 0.25 mg and 0.5 mg;
ibuprofen 5 mg/2 ml, ampoules; tablet, 5 mg.

List of additional medicines:
· SMPR (ulipristal acetate 5 mg);
· blood transfusion (according to indications).

N.B.! Anemia should be corrected before elective surgery (LE - II-2A). Selective progesterone receptor modulators and gonadotropin-releasing hormone agonists are effective in correcting anemia and should be used preoperatively (EL-I-A).

N.B.! The use of vasopressin, bupivacaine and epinephrine, misoprostol, a pericervical tourniquet, or thrombin matrices reduces blood loss during myomectomy and should be considered (EL-I-A).

Surgical intervention

Surgical planning should be based on accurate determination of the location, size and number of fibroids [EL-III-A]. In cases where morcellation must be used to remove a fibroid from the abdomen, the patient should be informed of the possible risks and complications, including the fact that in rare cases fibroids may contain elements of malignancy and that laparoscopic morcellation can spread the cancer, potentially worsening it prognosis [LE - III-B].

Curettage of the uterine cavity:
Indications:
· with uterine bleeding/

Hysterectomy
Indications:
· women who have completed childbearing;
· rapid growth of fibroids during menopause in women who do not use hormone replacement therapy (even in the absence of symptoms);
· suspicion of leiomyosarcoma.

NB! For women with asymptomatic uterine fibroids, with a low level of suspicion for a malignant process, hysterectomy is not indicated.
NB! Hysterectomy should not be recommended as a preventive measure for possible future fibroid growth.

Types of hysterectomy:
· vaginal hysterectomy;
· abdominal hysterectomy;
· there are clear indications and contraindications;
· VG with laparoscopic assistance.

NB! The choice of the type of hysterectomy, regardless of the approach (vaginal, laparoscopic or laparotomic), should be based on the experience, preferences of the surgeon and the objective status of the patient (size and number of myomatous nodes, previous surgical interventions, extragenital pathology, etc.). Whenever possible, it is preferable to use the least invasive approach to treatment.

Myomectomy
Indications: Women suffering from miscarriage or infertility, with the presence of one or more myomatous nodes deforming the uterine cavity (most often submucosal fibroids), myomectomy can help improve fertility and a successful pregnancy outcome.

NB! Myomectomy, as a surgical treatment method, allows you to preserve fertility, effectively eliminating the symptoms associated with uterine fibroids. [UD -C].
This is a treatment option for women who would like to preserve the organ or fertility but are at risk of further intervention (LE-II2). There is no evidence that the laparoscopic approach for myomectomy is more effective than the laparotomy approach [LE -C]. Myomectomy is an alternative to hysterectomy for women who wish to preserve the organ, regardless of their childbearing plans. Women should be advised of the risk of potentially extending the scope of surgery to hysterectomy during elective myomectomy. This will depend on the intraoperative findings and the progress of the operation.

Hysteroscopic myomectomy
Indications: symptomatic intracavitary uterine fibroids, submucosal fibroids (types 0, I and II), up to 4 to 5 cm in diameter.
NB! It should be carried out with caution in cases where the thickness between the uterine fibroids and the serous membrane is less than 5 mm.

Laparoscopic myomectomy:
Indications: fibroids in complex locations (lower segment or cervix), multiple nodes and/or large nodes (> 10 cm).

Laparoscopic myomectomy has advantages over laparotomic myomectomy in terms of less blood loss, postoperative pain, fewer overall complications, faster recovery, and significant cosmetic benefit [LE - B]
Uterine ruptures during pregnancy and childbirth after laparoscopic myomectomy are associated with inadequate suturing of deep defects with intramural fibroids or excessive use of electrosurgical energy [LE - C]. Compliance with a 6-month interval from myomectomy to pregnancy promotes better recovery of the myometrium.

Other types of treatment:

Uterine artery embolization:
Indications: symptomatic uterine fibroids, if desired, in patients who wish to preserve the organ, but do not plan a subsequent pregnancy.

NB! Women choosing UAE for the treatment of fibroids should be counseled regarding the potential risks, decreased fertility, and pregnancy outcomes [EL-II-3A].

High-intensity focused ultrasound with MRI assistance (FUS ablation)
Indications: uterine fibroid size less than or equal to 10 cm and total uterine size less than or equal to 24 weeks .

Indications for consultation with specialists:

Indications for transfer to the intensive care unit:
Acute cardiovascular and respiratory failure;
Acute DIC syndrome;
· disturbances of consciousness, convulsions;
· early postoperative period.

Indicators of treatment effectiveness:
· reduction in the size of uterine fibroids (with UAE, FUS ablation);
· reduction or disappearance of symptoms of the disease;
· removal of uterine and/or uterine fibroids.

Further management
There is no specific prevention. Patients are advised to consult a doctor if they experience abnormal uterine bleeding, pathological discharge from the genitals and other symptoms of recurrence of uterine fibroids after treatment.

Hospitalization

Indications for planned hospitalization:
· symptomatic fibroids (with hemorrhagic and pain syndrome, the presence of anemia, symptoms of compression of adjacent organs) in women who have completed their reproductive function;
· fibroid size 13-14 weeks or more;
presence of a submucosal node;
· suspicion of a power failure of the node;
· the presence of a subserous fibroid node on a stalk (due to the possibility of torsion of the node);
rapid growth (4-5 weeks per year or more) or resistance to GnRH therapy);
· fibroids in combination with endometrial hyperplastic process and/or ovarian tumor;
· infertility and/or miscarriage due to uterine fibroids, which deform the uterine cavity.

Indications for emergency hospitalization:
· uterine bleeding;
· clinic of acute abdomen (necrosis of the node, torsion of the leg of the node);
· severe pain syndromes (cramping pain in the lower abdomen with nascent uterine fibroids).

Information

Sources and literature

1. Minutes of meetings of the Joint Commission on the Quality of Medical Services of the Ministry of Health of the Republic of Kazakhstan, 2016
   1. 1. SOGC CLINICAL PRACTICE GUIDELINE. The Management of Uterine Leiomyomas. J Obstet Gynaecol Can 2015;37(2):157–178 2. Munro MG, Critchley HO, Broder MS, Fraser IS. The FIGO Classification System (“PALM-COEIN”) for causes of abnormal uterine bleeding in non-gravid women in the reproductive years, including guidelines for clinical investigation. Int J Gynaecol Obstet 2011;113:3–13 3. http://bestpractice.bmj.com/best-practice/monograph/567/diagnosis/differential.html 4. SOGC guideline on the management of uterine fibroids in women with otherwise unexplained infertility 2015 5. Uterine fibroids: a course for organ preservation. Newsletter / V.E. Radzinsky, G.F. Totchiev. - M.: Editorial office of the magazine StatusPraesens, 2014.

Information

Abbreviations used in the protocol

ESR	-	erythrocyte sedimentation rate
Ultrasound	-	ultrasound examination
MRI	-	magnetic resonance imaging
HRT	-	hormone replacement therapy
a- GnRH	-	gonadotropin releasing hormone agonists
COOK	-	combined oral contraceptives
OK	-	oral contraceptives
Navy	-	intrauterine system
ICE	-	syndrome - intravascular coagulation syndrome
VG	-	vaginal hysterectomy
AG	-	abdominal hysterectomy
NSAIDs	-	nonsteroidal anti-inflammatory drugs
EMA	-	uterine artery embolization
HELL	-	blood pressure
APTT	-	activated partial thromboplastin time
PV	-	prothrombin time
ALT	-	alanine aminotransferase
AST	-	aspartate aminotransferase
SMRP	-	selective progesterone receptor modulator
EGP	-	extragenital pathology
PAEC	-	Progesterone Receptor Modulator Associated Endometrial Changes (changes in the endometrium associated with an antagonistic effect on progesterone receptors)

List of protocol developers with qualification information:
1) Doschanova Aikerm Mzhaverovna - Doctor of Medical Sciences, professor, doctor of the highest category, head of the department of obstetrics and gynecology for internship at Astana Medical University JSC.
2) Toktarbekov Galymzhan Kabdulmanovich - obstetrician-gynecologist of the highest category, branch of the CF "UMC" NSCMD.
3) Tuletova Ainur Serikbaevna - PhD, doctor of the first category, assistant at the Department of Obstetrics and Gynecology of Astana Medical University JSC.
4) Mazhitov Talgat Mansurovich - Doctor of Medical Sciences, Professor, Astana Medical University JSC, clinical pharmacologist of the highest category.

Conflict of interest: No.

List of reviewers: Kalieva Lira Kabbasovna - Doctor of Medical Sciences, Head of the Department of Obstetrics and Gynecology No. 2, RSE at the PVC “Kazakh National Medical University named after S.D. Asfendiyarov."

Indication of the conditions for reviewing the protocol: Review of the protocol 3 years after its publication and from the date of its entry into force or if new methods with a level of evidence are available.

Attached files

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UTERINE FIBROID: DIAGNOSIS, TREATMENT AND REHABILITATION

AGREED

Chief freelance specialist of the Russian Ministry of Health in obstetrics and gynecology, Academician of the Russian Academy of Sciences L.V. Adamyan

21/09 from 2015

I APPROVED

President of the Russian Society of Obstetricians and Gynecologists V.N. Serov

21/09 from 2015


Team of authors:

Adamyan Leila Vladimirovna	Deputy Director of the Federal State Budgetary Institution "Scientific Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, chief freelance specialist in obstetrics and gynecology of the Ministry of Health of Russia, academician of the Russian Academy of Sciences, professor
Andreeva Elena Nikolaevna	Head of the Department of Endocrine Gynecology of the Federal State Budgetary Institution "Endocrinological Research Center" of the Ministry of Health of Russia, Professor of the Department of Reproductive Medicine and Surgery of the State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of Russia, Doctor of Medical Sciences.
Artymuk Natalya Vladimirovna	Head of the Department of Obstetrics and Gynecology, Kemerovo State Medical Academy, Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Belotserkovtseva Larisa Dmitrievna	Head of the Department of Obstetrics, Gynecology and Perinatology, Surgut State University, Chief Physician of the Surgut Clinical Perinatal Center, Doctor of Medical Sciences, Professor
Bezhenar Vitaly Fedorovich	Head of the Department of Operative Gynecology of the Federal State Budgetary Institution "Research Institute of Obstetrics and Gynecology named after D.O. Ott", Doctor of Medical Sciences, Professor
Gevorkyan Mariyana Aramovna
Glukhov Evgeniy Yurievich	Associate Professor of the Department of Obstetrics and Gynecology, Ural State Medical University, Ministry of Health of Russia, Deputy Chief Physician for Obstetrics and Gynecology, Central City Hospital No. 7, Yekaterinburg, Ph.D.
Gus Alexander Iosifovich	Head of the Department of Functional Diagnostics of the Federal State Budgetary Institution "Scientific Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Dobrokhotova Yulia Eduardovna	Head of the Department of Obstetrics and Gynecology No. 2, Faculty of Medicine, State Budgetary Educational Institution of Higher Professional Education "Russian National Research Medical University named after N.I. Pirogov" of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Jordania Kirill Iosifovich	Leading Researcher of the Federal State Budgetary Institution "Russian Oncology Research Center named after N.N. Blokhin" of the Ministry of Health of Russia, Professor of the Department of Reproductive Medicine and Surgery of the State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of Russia, Doctor of Medicine. Sc., professor
Zayratiants Oleg Vadimovich	Head of the Department of Pathological Anatomy of the State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of Russia, chief pathologist of Roszdravnadzor for the Central Federal District of the Russian Federation, Vice-President of the Russian and Chairman of the Moscow Society of Pathologists, Laureate of the A. I. Strukova RAMS, Doctor of Medical Sciences, Professor
Kozachenko Andrey Vladimirovich	Leading Researcher of the Gynecological Department of the Department of Operative Gynecology and General Surgery of the Federal State Budgetary Institution "Scientific Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Associate Professor of the Department of Reproductive Medicine and Surgery of the State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A. .I.Evdokimov" Ministry of Health of Russia, Doctor of Medical Sciences
Kiselev Stanislav Ivanovich	Professor of the Department of Reproductive Medicine and Surgery of the State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of Russia, laureate of the Government of the Russian Federation Prize in the field of science and technology, Doctor of Medical Sciences.
Kogan Evgenia Altarovna	Head of the 1st pathological department of the Federal State Budgetary Institution "Scientific Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Professor of the Department of Pathological Anatomy of the National Research Center of the State Budgetary Educational Institution of Higher Professional Education "First Moscow State Medical University named after I.M. Sechenov", Doctor of Medicine .Sc., professor
Kuznetsova Irina Vsevolodovna	Chief Researcher of the Research Department of Women's Health of the Scientific and Educational Clinical Center of the State Budgetary Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Kurashvili Yulia Borisovna	Professor, Department of Medical Physics, National Research Nuclear University "MEPhI", Doctor of Medical Sciences
Leftists Sergey Alexandrovich	Head of the Department of Complex and Combined Methods for the Treatment of Gynecological Diseases of the Federal State Budgetary Institution "Scientific Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Malyshkina Anna Ivanovna	Director of the Federal State Budgetary Institution "Ivanovo Research Institute of Motherhood and Childhood named after V.N. Gorodkov" of the Ministry of Health of Russia, Doctor of Medical Sciences.
Maltseva Larisa Ivanovna	Head of the Department of Obstetrics and Gynecology, HBO DPO "Kazan State Medical Academy", chief freelance obstetrician-gynecologist in the Volga Federal District, Doctor of Medical Sciences, Professor
Marchenko Larisa Andreevna	Leading Researcher of the Department of Gynecological Endocrinology of the Federal State Budgetary Institution "Scientific Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Murvatov Kamoljon Jamolkhonovich	Head of the Gynecological Department of the Main Military Clinical Hospital of the Ministry of Internal Affairs of Russia, Colonel of the Medical Service, Associate Professor of the Department of Reproductive Medicine, Moscow State Medical and Dental University named after A.I. Evdokimov, Ministry of Health of Russia, Ph.D.
Pestrikova Tatyana Yurievna	Head of the Department of Obstetrics and Gynecology, Far Eastern State Medical University, Ministry of Health of Russia (Khabarovsk), chief freelance obstetrician-gynecologist in the Far Eastern Federal District, Doctor of Medical Sciences, Professor
Popov Alexander Anatolyevich	Head of the Department of Endoscopy, Moscow Regional Research Institute of Obstetrics and Gynecology, Doctor of Medical Sciences, Professor
Protopopova Natalya Vladimirovna	Head of the Department of Perinatal and Reproductive Medicine, Irkutsk State Medical Academy of Postgraduate Education, Doctor of Medical Sciences, Professor
Samoilova Alla Vladimirovna	Deputy Chairman of the Cabinet of Ministers of the Chuvash Republic - Minister of Health and Social Development of the Chuvash Republic, Head of the Department of Obstetrics and Gynecology of the Chuvash State Medical University named after I.N. Ulyanov, Doctor of Medical Sciences, Professor
Sonova Marina Musabievna	Head of the Department of Gynecology, Department of Reproductive Medicine, State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Tikhomirov Alexander Leonidovich	Professor of the Department of Obstetrics and Gynecology of the Medical Faculty of the State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of Russia, Doctor of Medical Sciences.
Tkachenko Lyudmila Vladimirovna	Head of the Department of Obstetrics and Gynecology, Federal Educational Institution of Higher Professional Education "Volgograd State Medical University" of the Ministry of Health of Russia, Chief Freelance Obstetrician-Gynecologist of the Volgograd Region, Doctor of Medical Sciences, Professor
Urumova Lyudmila Tatarkanovna	Head of the Gynecological Department of the Federal State Budgetary Institution "Clinical Hospital No. 123 of the Federal Medical and Biological Agency" of Russia, Ph.D.
Filippov Oleg Semenovich	Deputy Director of the Department of Medical Care for Children and Obstetrics Service of the Ministry of Health of Russia, Professor of the Department of Obstetrics and Gynecology of the IPO GBOU VPO "Moscow State Medical University named after I.M. Sechenov" Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Khashukoeva Assiyat Zulchifovna	Professor of the Department of Obstetrics and Gynecology of the Medical Faculty of the State Budgetary Educational Institution of Higher Professional Education "Russian National Research Medical University named after N.I. Pirogov" of the Ministry of Health of Russia, Doctor of Medical Sciences.
Chernukha Galina Evgenievna	Head of the Department of Gynecological Endocrinology, Federal State Budgetary Institution "Scientific Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor
Yarmolinskaya Maria Igorevna	Leading Researcher of the Department of Endocrinology of Reproduction of the Federal State Budgetary Institution "Research Institute of Obstetrics and Gynecology named after D.O. Ott", Professor of the Department of Obstetrics and Gynecology No. 2 of the State Budgetary Educational Institution of Higher Professional Education "North-Western State Medical University named after I.I. Mechnikov" of the Ministry of Health of Russia, Dr. M.Sc.
Yarotskaya Ekaterina Lvovna	Head of the Department of International Cooperation of the Federal State Budgetary Institution "Scientific Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" of the Ministry of Health of Russia, Doctor of Medical Sciences.

The following authors took part in the work:

Baranov B.S. (St. Petersburg), Ivashchenko T.E. (St. Petersburg), Osinovskaya N.S. (St. Petersburg), Obelchak I.S. (Moscow), Panov V.O. (Moscow), Pankratov V.V. (Surgut), Grishin I.I. (Moscow), Ibragimova D.M. (Moscow), Khachatryan A.S. (Moscow)

Reviewers:

Pasman Natalya Mikhailovna	Head of the Department of Obstetrics and Gynecology, Faculty of Medicine, NSU, Head of the Laboratory of Reproductive Immunology, Institute of Clinical Immunology, Siberian Branch of the Russian Academy of Medical Sciences (Novosibirsk), Doctor of Medical Sciences, Professor
Shtyrov Sergey Vyacheslavovich	Professor of the Department of Obstetrics and Gynecology of the Pediatric Faculty of the State Budgetary Educational Institution of Higher Professional Education "Russian National Research Medical University named after N.I. Pirogov" of the Ministry of Health of Russia, Doctor of Medical Sciences.
Faizullin Ildar Faridovich	Head of the Department of Obstetrics and Gynecology, Kazan State Medical University, Ministry of Health of Russia, Chairman of the Society of Obstetricians and Gynecologists of the Republic of Tatarstan, Honored Scientist of the Republic of Tatarstan, Doctor of Medical Sciences, Professor

ANNOTATION

ANNOTATION

Uterine fibroids - a benign, monoclonal, well-demarcated, encapsulated tumor originating from the smooth muscle cells of the cervix or uterine body - one of the most common benign tumors of the female genital area, which occurs in 20-40% of women of reproductive age. The localization of uterine fibroids can be very diverse. The most frequently diagnosed subserous and intermuscular (intramural) location of myomatous nodes, the number of which can reach 25 or more, and the size can increase significantly. The submucosal (submucosal) location of the nodes is observed less frequently, but it is accompanied by a more vivid clinical picture.

These recommendations present current data on the etiology, pathogenesis, clinical picture, diagnosis, as well as new possibilities for surgical treatment and the role of hormonal therapy in the complex treatment of uterine fibroids.

1. EPIDEMIOLOGY, ETIOLOGY, PATHOGENESIS AND RISK FACTORS

Uterine fibroids are the most common benign tumor among women in most countries of the world. It is believed that uterine fibroids are diagnosed in 30-35% of women of reproductive age, more often in late reproductive age, and in 1/3 of patients it becomes symptomatic.

As a result, uterine fibroids become the main reason for hysterectomy in many countries, for example in the USA it is the basis for approximately 1/3 of all hysterectomies, which is approximately 200 thousand hysterectomies annually. In Russia, according to various data, uterine fibroids are the reason for hysterectomy in 50-70% of cases with diseases of the uterus.

Despite the high prevalence of the disease, until recent years, relatively few fundamental studies have been aimed at identifying the causation and pathogenesis of uterine fibroids due to the rarity of its malignant transformation. However, despite its benign course, uterine fibroids cause a significant decrease in the quality of life in a significant part of the female population. Clinical manifestations of the tumor are associated with uterine bleeding, pain, compression of adjacent organs, disruption of not only their function, but also fertility, including infertility and miscarriage.

The causes of uterine fibroids are unknown, but the scientific literature contains a large amount of information related to the epidemiology, genetics, hormonal aspects and molecular biology of this tumor.

Factors potentially associated with tumor genesis can be roughly divided into 4 categories:

		Predisposing or risk factors;
		Initiators;
		Promoters;
		Effectors.

Risk factors for uterine fibroids (predisposing)

Knowledge of predisposition factors will allow us to understand the etiology of uterine fibroids and develop preventive measures. Despite the fact that we consider risk factors in isolation, most often there is a combination of them (Table 1). The effects of many factors have previously been attributed to their influence on the levels or metabolism of estrogen and progesterone, but this relationship has been shown to be extremely complex and there are likely other mechanisms involved in tumor formation. It should be noted that the analysis of risk factors for uterine fibroids remains difficult due to the relatively small number of epidemiological studies conducted, and their results may be influenced by the fact that the prevalence of asymptomatic cases of uterine fibroids is quite high.

The most important aspect of the etiology of uterine fibroids - the initiator of tumor growth - remains unknown, although theories of the initiation of its tumorigenesis exist. One of them confirms that an increase in the level of estrogen and progesterone leads to an increase in mitotic activity, which can contribute to the formation of fibroid nodes, increasing the likelihood of somatic mutations. Another hypothesis suggests the presence of congenital genetically determined pathology of the myometrium in women with uterine fibroids, expressed in an increase in the number of ER in the myometrium. The presence of a genetic predisposition to uterine fibroids indirectly indicates the ethnic and family nature of the disease.

In addition, the risk of uterine fibroids is higher in nulliparous women, who may be characterized by a large number of anovulatory cycles, as well as obesity with pronounced aromatization of androgens into estrone in adipose tissue. According to one hypothesis, estrogens play a fundamental role in the pathogenesis of uterine fibroids.

This hypothesis was confirmed by clinical trials that assessed the effectiveness of treatment of uterine fibroids with gonadotropin-releasing hormone agonists (Gn-RH); during therapy, hypoestrogenemia was observed, accompanied by regression of myomatous nodes. However, it is impossible to talk about the fundamental importance of estrogens independently of progesterone, since the content of progesterone in the blood, like estrogens, changes cyclically during reproductive age, and is also significantly increased during pregnancy and decreased after menopause. Thus, clinical and laboratory studies suggest that both estrogens and progesterone may be important stimulators of fibroid growth.

Table 1

Risk factors associated with the development of fibroids

Factor
Early menarche	Increases	Marshalltal. 1988a
No history of childbirth		Parazzinietal. 1996a
Age (late reproductive period)		Marshalletal. 1997
Obesity		Rossetal. 1986
African American race		Bairdetal. 1998
Taking tamoxifen		Deligdisch, 2000
High parity	Reduces	Lumbiganonetal, 1996
Menopause		Samadietal, 1996
Smoking		Parazzinietal, 1996b
Taking COCs		Marshalletal, 1998a
Hormone therapy		Schwartztal, 1996
Nutritional factors		Chiaffarinoetal, 1999
Foreign estrogens		Saxenaetal, 1987
Geographical factor		EzemandOtubu, 1981

3. TERMINOLOGY AND CLASSIFICATION

________________
* Numbering corresponds to the original, hereinafter in the text. - Database manufacturer's note.


Terminology . Ancient healers already had information about uterine fibroids. When examining the remains of ancient Egyptian mummies, cases of calcified uterine fibroid nodules were identified. Hippocrates called them "uterine stones."

0. pedunculated submucosal nodes without an intramural component.

I. Submucosal nodes on a broad base with an intramural component of less than 50%.

II. Myomatous nodes with an intramural component of 50% or more.

According to the recommendations of the European Society of Human Reproduction (ESHRE), fibroids up to 5 cm should be considered small, and fibroids larger than 5 cm should be considered large.

International Classification of Diseases, Tenth Revision (ICD 10):

D25 Leiomyoma of the uterus,

D25.0 Submucosal leiomyoma of the uterus,

D25.1 Intramural leiomyoma,

D25.2 Subserous leiomyoma

D25.9 Leiomyoma, unspecified.

D26 Other benign neoplasms of the uterus

D26.0 Benign neoplasm of the cervix

D26.1 Benign neoplasm of the uterine body

D26.7 Benign neoplasm of other parts of the uterus

D26.9 Benign neoplasm of the uterus, unspecified part

O34.1 Tumor of the uterine body (during pregnancy), requiring medical care for the mother.

4. CLINICAL PICTURE

5. DIAGNOSTICS

Ultrasound diagnosis of the uterus

The main method of screening and primary diagnosis in gynecology, the “gold standard” of instrumental diagnostics in this area, without a doubt, has been and remains ultrasound. At the same time, the reliability of ultrasound results depends not only on the experience and knowledge of the diagnostician, but also on his manual skills in using an ultrasound sensor, i.e. Ultrasound is a rather subjective or “operator-dependent” method. It is impossible not to note the objective limitations of the method - the need to have acoustic windows of the required size in the study area, which is not always possible.

However, ultrasound examination using transabdominal and transvaginal sensors is a method of primary diagnosis of uterine fibroids, and it is also widely used for dynamic monitoring of the development of the tumor process, selection of patients and assessment of the effectiveness of various types (conservative and/or surgical) therapeutic interventions. Based on prognostic acoustic signs, echography provides the opportunity not only for topical diagnosis of myomatous nodes, but also their structure, hemodynamics and, accordingly, the severity of proliferative processes, differentiation from other myometrial pathologies (adenomyosis, sarcoma, etc.).

Modern 3/4D technologies make it possible to obtain in the coronal scanning plane additional information on the spatial localization in relation to the uterine cavity of intermuscular with centripetal growth and submucosal nodes.

Echohysterography against the background of installed fluid and dilation of the walls of the uterine cavity, it significantly expands the possibilities of contouring the node, thereby detailing its localization in the uterine cavity. Thus, with an intermuscular-submucosal location of the node, a clear structure of the endometrium is revealed, and with its submucosal localization, the latter is completely located in the uterine cavity. The additional information obtained from echohysterography facilitates the choice of therapeutic measures.

Along with the echographic picture of the structure of the myomatous node with color Doppler mapping (CDC) evaluate the qualitative and quantitative parameters of its blood flow. In the vast majority of cases, non-mosaic blood flow is recorded along the periphery and only in 1/3 - within it. With the so-called proliferating nodes, the type of blood flow is diffuse or mixed. Evaluation of the quantitative parameters of blood flow during colorectal circulation allows one to predict the tumor histotype. Thus, the blood flow velocity () in simple and proliferating fibroids is low and ranges from 0.12 to 0.25 cm/sec, and the resistance index (RI) is 0.58-0.69 and 0.50-0.56 respectively. The high speed of arterial mosaic blood flow (0.40 cm/sec) in combination with low resistance index values ​​(RI0.40) allows one to suspect uterine sarcoma.

X-ray examination, computed tomography and magnetic resonance imaging in the diagnosis of uterine fibroids

Currently, X-ray studies previously used to visualize the pathology of the uterus and its appendages (gas and bicontrast X-ray pelviography, intrauterine pelvic phlebography, etc.) are historical in nature and have not been developed due to the emergence of other modern radiation research methods. Traditional X-ray examinations are used in limited cases and most often only for the diagnosis of tubal infertility - hysterosalpingography.

The use of modern multi-slice computed tomography (MSCT or CT), especially with artificial contrast, allows with high resolution not only to determine the condition and relationship of the pelvic organs, bone structures and pelvic vessels, but also to diagnose the presence of bleeding in the acute period, and also to introduce it into gynecology methods of interventional radiology. CT scans of the pelvic organs are often performed with the patient in the supine position.

However, radiation diagnostic methods using ionizing radiation in gynecologists, and especially when examining girls, girls and women of reproductive age, are understandably undesirable due to radiation exposure, which means that in the vast majority of clinical cases they should be used only under strict conditions. clinical indications, the impossibility of replacing them with safer methods or when carrying out low-traumatic treatment measures, such as, for example, selective salpingography and x-ray surgical recanalization of the proximal parts of the fallopian tubes in case of their obstruction, embolization of the uterine arteries in the treatment of uterine fibroids, etc.

Spiral/multispiral computed tomography

With SCT with intravenous contrast enhancement, fibroids are determined as a soft tissue formation that causes deformation and/or protrusion beyond the outer contour of the uterus or deforms the uterine cavity. Uterine fibroids have a clearly defined capsule and a homogeneous structure with a soft tissue density of 40-60 HU.

With multi-slice spiral CT of fibroids with the introduction of radiocontrast agents, it is possible to obtain data on the condition of the pelvic vessels, which is very important for identifying the main feeding vessel when planning radiosurgical treatment of fibroids by embolization of the uterine artery.

Multiple fibroids are defined as a single conglomerate of soft tissue density with smooth, clear contours, oval in shape with a homogeneous internal structure. With large fibroids, compression and deformation of the bladder and ureters can be observed. With the development of degenerative-necrotic changes, the structure of the fibroid becomes heterogeneous, with areas of reduced density due to impaired blood supply. With submucous fibroids, a soft tissue formation is identified in the center of the uterus, repeating the configuration of the uterine cavity. Its contours are smooth, clear, surrounded by a hypodense rim of the endometrium, pushed aside by the node. In the parenchymal phase of contrasting, the myomatous node clearly stands out against the background of the surrounding myometrium. Often, calcifications form in myomatous nodes in the form of single inclusions and massive areas.

Magnetic resonance imaging

Myomatous nodes on MP tomograms are represented by formations with clear boundaries, with smooth or slightly bumpy contours. As a rule, a characteristic feature of myomatous nodes on MRI in the first phase of the menstrual cycle is a low intensity of the MP signal on T2WI, close to the MP signal from skeletal muscles. Less commonly, myomatous nodes are detected in the form of formations with an average MP signal intensity, isointense to the myometrium, due to the pronounced collagen content and blood supply characteristics. For small nodes, their homogeneous structure is more characteristic. The minimum diameter of detected nodes is about 0.3-0.4 cm. For smaller formations, similar in MP characteristics to myomatous nodes, uterine vessels caught in the cross-section of the tomograph can be taken. The characteristics of myomatous nodes can change due to not only a sharp change in blood flow during menstruation, but also degenerative processes in the node. Less commonly, cystic transformation is determined, as well as hemorrhages into the myomatous node, which are more typical for large nodes, which, as a rule, have a heterogeneous structure.

In general, MRI of the pelvic organs, regardless of the phase of the cycle, can identify 5 types of myomatous nodes:

1 - with a homogeneous hypointense MP signal, similar to skeletal muscles;

2 - with a heterogeneous predominantly hypointense structure, but with areas of hyperintense inclusions due to degeneration with the formation of edema and hyalinosis;

3 - with an isointense MP signal similar to myometrial tissue, due to the low collagen content;

4 - with a high MP signal due to cystic degeneration;

5 - with a varying MP signal on T2WI and a high, with varying degrees of intensity, on T1WI with degenerative changes with hemorrhage.

Myomas with degenerative changes (hyaline, cystic) have a characteristic spotty or homogeneous appearance with a heterogeneous signal intensity. When calcified, the fibroid appears as a formation with uniformly high signal intensity, clearly delineated by a ring of low intensity from the surrounding myometrium.

6. TREATMENT

The management of patients with uterine fibroids includes observation and monitoring, drug therapy, various surgical methods and the use of new minimally invasive approaches. For each patient, individual management tactics are developed, i.e. the approach must be strictly personalized.

6.1 Surgical treatment

Indications for surgical treatment

Most patients with uterine fibroids require surgical treatment. Indications for surgery are identified in approximately 15% of patients. The generally accepted indications for surgical treatment are: heavy menstrual bleeding leading to anemia; chronic pelvic pain, significantly reducing quality of life; disruption of the normal functioning of internal organs adjacent to the uterus (rectum, bladder, ureters); large tumor size (more than 12 weeks of the pregnant uterus); rapid tumor growth (increase by more than 4 weeks of pregnancy within 1 year); tumor growth in postmenopause; submucosal location of the fibroid node; interligamentous and low (cervical and isthmus) location of fibroid nodes; reproductive dysfunction; infertility in the absence of other reasons.

As a rule, surgical treatment is performed routinely in the first phase of the menstrual cycle (days 5-14). Emergency surgery is necessary for spontaneous expulsion ("birth") of a submucosal myomatous node, for degenerative changes in the tumor due to circulatory disorders, accompanied by signs of infection and the appearance of symptoms of an "acute abdomen", as well as for the ineffectiveness of ongoing antibacterial and anti-inflammatory therapy. Degenerative changes in myomatous nodes, which naturally occur during the development of a tumor, are often detected using a variety of visualizations of additional research methods (ultrasound, MPT, CT) and do not have the above symptoms, are not an indication for surgical treatment. Multiple small uterine fibroids that do not cause symptoms are also not an indication for surgery. Some national guidelines (ACOG Pract. Bull. N 96, 2008) dispute the need for surgical treatment only on the basis of clinically diagnosed rapid tumor growth outside the postmenopausal period (B).

Scope of surgical treatment

A patient with uterine fibroids for whom surgery is indicated should have full information about the advantages and disadvantages of radical and organ-preserving surgical treatment. The final decision on the extent of the operation and access should be made by the patient herself together with the surgeon (attending physician), signing an informed consent for the operation and being aware of the possibility of complications.

Hysterectomy. The only method of surgical treatment that leads to a complete cure (radical) is a total hysterectomy - hysterectomy. (Level of Evidence IA). Subtotal hysterectomy (supravaginal amputation of the uterus) is not a completely radical intervention, but it can be performed after confirmation of the condition of the cervix (colposcopy, biopsy if indicated) (Level of Evidence IA). When combined with adenomyosis, given the absence of a clear boundary of the disease, supravaginal amputation is not recommended, since incomplete removal of the above pathological processes is possible, which in the future may be the reason for another operation (removal of the stump of the cervix and other pelvic organs - the distal ureter), since this is a more complex intervention due to the development of adhesive-scarring processes involving the bladder. And although relapses of fibroids in the cervical stump occur rarely, in 15-20% of patients after surgery of this volume, cyclic bleeding from the genital tract is observed, which indicates incomplete removal of myometrial and endometrial tissue. Total hysterectomy provides not only a radical cure for uterine fibroids, but also prevention of the occurrence of any future cervical disease. In countries that do not have comprehensive cytological screening, total hysterectomy should be considered as one of the measures to prevent cervical cancer. Hypotheses regarding the benefits of subtotal hysterectomy compared with total hysterectomy in terms of negative effects on urinary tract function, sexual function and overall quality of life have not been confirmed in numerous multicenter randomized trials. According to the American Congress of Obstetricians and Gynecologists (ACOG Comm.Opin. N 388, 2007), subtotal hysterectomy should not be recommended as the best option for removing the uterus for benign diseases. The patient must be informed about the absence of scientifically proven differences between total and subtotal hysterectomy in their effect on sexual function, as well as about the possible recurrence of fibroids and the occurrence of other benign and malignant diseases in the cervical stump, for the treatment of which surgical treatment is necessary in the future.

Access operation

Data from modern evidence-based medicine indicate that the best surgical approach for removing the uterus is the vaginal approach. Vaginal hysterectomy is characterized by shorter duration, blood loss, and the incidence of intra- and postoperative complications. However, to use this access for uterine fibroids, a number of conditions are necessary: ​​sufficient vaginal capacity and uterine mobility, small size and weight of the tumor (less than 16 weeks and 700 g), absence of pronounced adhesions in the pelvic cavity and the need for combined operations on the uterine appendages and/or abdominal organs. If conditions for vaginal hysterectomy are not available, laparoscopic hysterectomy should be performed. Laparotomic hysterectomy, which does not have any advantages over laparoscopic and vaginal analogues, is necessary only for a small number of patients with extremely large tumors (more than 24 weeks and 1500 g) or when anesthesia is contraindicated. Laparotomy hysterectomy can also be performed in the absence of technical capabilities and conditions for performing endoscopic surgery (equipment, surgical team). The above limits for the size and weight of the uterus when it is removed by vaginal or laparoscopic access are conditional and depend on the experience of each individual surgeon. Regardless of the approach, total hysterectomy should use an intrafascial technique that allows maximum preservation of integration between the pelvic fascia and the supporting ligamentous apparatus of the uterus.

Myomectomy

Although a total hysterectomy is a radical operation, it should not be recommended for young women or those who wish to preserve the uterus and/or reproductive function. If there are indications for surgical treatment, these categories of patients undergo organ-saving operations - myomectomies. Indications for myomectomy are also infertility or miscarriage in the absence of any other reasons other than uterine fibroids. The relationship between uterine fibroids and infertility is not clearly defined. However, the results of a number of studies with a high level of evidence have shown that myomatous nodes in contact with the uterine cavity can cause infertility. There is evidence of improved ART results after myomectomy in women with unspecified infertility. To date, none of the existing diagnostic methods can identify all pathological foci either before surgery or during its process. The risk of recurrence (possibly persistence in most cases) is higher in the presence of multiple fibroids. With a single node it is 27%, the risk of reoperation associated with relapse is 11%, and with multiple nodes it is 59 and 26%, respectively.

Access operation

The choice of myomectomy approach is a rather complex task, depending not only on objective factors such as the size of the tumor, its location, the multiplicity of pathological changes, but also on the experience of a particular surgeon.

Submucosal myomatous nodes (ESGE type 0-II), not exceeding 5-6 cm in diameter, are removed hysteroscopically using a mono- or bipolar resectoscope or an intrauterine morcellator. If it is technically impossible to completely remove a type II node, a two-stage operation is indicated. During the 3-month break between stages, the patient is prescribed GnRH therapy, which promotes shrinkage of the uterus and migration of unremoved remnants of the node into the uterine cavity. Hysteroscopic myomectomy may be an alternative to hysterectomy in postmenopausal women in whom, due to uterine contractions, myomatous nodes located near the cavity migrate into it. In premenopausal women who are not interested in preserving reproductive function, it is advisable to combine hysteroscopic myomectomy with endometrial resection.

For patients with single myomatous nodes of subserous and interstitial localization, even if they are significant in size (up to 20 cm), it is advisable to undergo laparoscopic myomectomy. The indicated maximum diameter of the node is a conditional limit, especially if it is subserous. The same approach to choosing an access should be followed in the presence of multiple subserous fibroids. In all cases, the wound on the uterus must be sutured in layers, just as with vaginal or laparotomy myomectomy. An extracorporeal knot tying technique should be used, which ensures a sufficient degree of thread tension and full alignment of the wound edges. Laparoscopic myomectomy can be combined with hysteroscopic in patients with an association of subserous and submucosal nodes.

The disadvantages of the laparoscopic approach are the inability to palpate the search for intermuscular nodes and their enucleation using additional myometrial incisions in the bed of the main node. In case of multiple interstitial fibroids or associations of multiple nodes of different localizations, it is advisable to perform laparotomy myomectomy.

In all cases of nascent or born submucosal tumors, myomectomy is performed through the vaginal approach. In the presence of single subserous and intermuscular nodes located on the posterior wall of the uterus or in its fundus, myomectomy can be performed via vaginal access through the posterior colpotome opening. In this way, fibroids up to 8-12 cm in diameter can be removed using the node fragmentation technique. The vaginal approach is most suitable for fibroids located partially or entirely in the vaginal part of the cervix.

Assistive surgical technologies

One of the main problems of myomectomy is the fight against intraoperative bleeding. To reduce blood loss, both vasoconstrictor agents (vasopressin) and various methods of mechanical occlusion of the vessels supplying the uterus (tourniquets, clamps, ligation, coagulation or embolization of the uterine arteries) are used. Vasoconstrictors have been banned in some countries due to reports of fatal cardiovascular complications following topical use of these drugs. In any case, when using these drugs, it is necessary to warn the anesthesiologist, taking into account the vascular effect on increasing blood pressure.

The second important problem of myomectomy is the occurrence of postoperative adhesions. Today, the most successful methods of preventing adhesions are considered to be barrier methods (mesh, gels, solutions), which provide temporary delimitation of the wound from the adjacent anatomical structures.

What is new is the proven use of abdominal conditioning during endoscopic surgery with controlled temperature, humidity and supplemental oxygen.

Postoperative management

After a total hysterectomy, the only restriction for the patient is refusal of sexual activity for 1.5-2 months. Patients after subtotal hysterectomies should undergo regular cytological examination of the cervical epithelium.

Patients after myomectomy should be protected from pregnancy for 6-12 months, depending on the depth of damage to the uterine wall during surgery. Oral contraceptives should be considered the most suitable method of contraception. You can become pregnant after 1 year.

Postoperative anti-relapse treatment with GnRH is not indicated, as it reduces blood supply to the uterus and, therefore, impairs wound healing.

The issue of failure of the uterine scar after endoscopic myomectomies, which is raised in modern Russian literature, requires careful analysis. In the foreign literature, there is only one work in which 19 cases of uterine rupture were analyzed in the period from 17 to 40 weeks of pregnancy after myomectomy from 1992 to 2004. Only in 3 cases (18%) the fibroid nodes were more than 5 cm in diameter, and in In 12 cases (63%) they did not exceed 4 cm in diameter. Wound hemostasis was carried out without coagulation in only 2 cases (10%). In 7 (37%) cases the wound was not sutured. None of the women died; 3 fetuses (18%) died at 17, 28 and 33 weeks of gestation. There are only 2 case reports of uterine rupture during pregnancy after hysteroscopic myomectomies.

In addition, problems with the blood coagulation system, such as von Willebrand disease, can cause postoperative bleeding. They can be stopped by embolization of the uterine arteries. For the first time, embolization of the uterine arteries and vascular collaterals in obstetric and gynecological practice was used at the All-Russian Research Center for Healthcare and Healthcare of the USSR Ministry of Health in 1984 (L.V. Adamyan).

Since the late 70s, X-ray endovascular embolization of the uterine arteries has been used in obstetric and gynecological practice:

- to stop bleeding in the postpartum period;

- with hydatidiform mole;

- after caesarean section;

- for conservative myomectomy and hysterectomy;

- to stop bleeding in inoperable malignant tumors;

- for preoperative devascularization of vascular tumors and arteriovenous anomalies in order to facilitate their removal and reduce blood loss.

Uterine artery embolization in the treatment of uterine fibroids

Currently, endovascular embolization of the uterine arteries is a promising radiosurgical intervention for the treatment of fibroids.

Many patients categorically refuse surgical or hormonal treatment, which is due to the psycho-emotional status of the patient or the desire to preserve their own reproductive function.

Over the last decade, uterine artery embolization as an independent method of treating uterine fibroids has attracted particular interest. The minimal invasiveness of endovascular intervention performed under local anesthesia, the effectiveness of the method leading to a decrease or disappearance of the symptoms of uterine fibroids, preservation of the woman’s reproductive function, and short hospitalization are important and determining factors for the patients themselves.

Indications for uterine artery embolization: symptomatic uterine fibroids.

Uterine artery embolization (UAE) is an alternative to surgical treatment (Level of Evidence B).

Contraindications to uterine artery embolization: pregnancy, inflammatory diseases of the pelvic organs in the acute stage, allergic reactions to a contrast agent, arteriovenous malformations, undifferentiated tumor formation in the pelvis, suspicion of leiomyosarcoma.

Instrumental and laboratory studies before the procedure include all those that are accepted for elective surgical treatment, including:

bacterioscopic examination of the vaginal microflora (if inflammatory changes are detected, it is necessary to carry out antibacterial therapy - possibly local application, in order to reduce the inflammatory complications of UAE) ( level of evidence B);

oncocytological examination of the endo- and exocervix;

ultrasound examination of the pelvic organs and vessels with determination of the speed of blood flow through the uterine, ovarian arteries and their branches. To assess the parameters of blood flow through the vessels of the uterus, triplex ultrasound angioscanning (USAS) is used, including scanning of blood vessels in B-mode, Doppler sonography and color Doppler mapping of blood flow;

hysteroscopy and separate diagnostic curettage, followed by pathohistological examination - in case of ovarian dysfunction, an increase in the median m-echo that does not correspond to the day of the menstrual cycle;

consultation with a gynecologist, interventional radiologist. UAE should be performed by experienced interventional radiologists familiar with the technique of the procedure, as well as the peculiarities of the blood supply to myomatous nodes ( level of evidence C);

when a tumor of the ovary or one of the nodes is detected with multiple growth patterns of the subserous type on a thin base, surgical laparoscopy is performed - removal of the ovarian mass before UAE, followed by pathohistological examination, and removal of the myomatous node - after UAE in order to reduce the volume of blood loss and the risk of “untying” the node into the abdominal cavity.

Special cases
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3.1 Conservative treatment.
  It is not recommended to prescribe medications for asymptomatic fibroids, with the exception of large tumors.
  Strength of recommendation: A (level of evidence: 1a).
  It is recommended to prescribe medications or surgical treatment in the presence of abnormal uterine bleeding, anemia, pain in the pelvic area and concomitant hyperplastic processes of the endometrium.
  Strength of recommendation: C (level of evidence: 4).
  Comments. It should be understood that the only goal of drug treatment is to alleviate or eliminate symptoms associated with uterine fibroids and regression of fibroid nodes.
  The use of non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for dysmenorrhea in patients with uterine fibroids.
  Strength of recommendation: B (level of evidence: 2a).
  Comments. For uterine fibroids, these drugs can reduce significant menstrual blood loss, but are less effective than tranexamic acid**, danazol, or the levonorgestrel intrauterine system (LNG-IUD).
  It is recommended to use antifibrinolytics, in particular tranexamic acid**, as first-line non-hormonal drugs for abnormal uterine bleeding.

  It is recommended to use progestogens to reduce the amount of abnormal uterine bleeding and increase hemoglobin levels, as well as to prevent endometrial hyperplastic processes associated with uterine fibroids.
  Strength of recommendation: B (level of evidence: 2b).
  Comments. Progestogens have no effect on stabilizing or reducing the growth of myomatous nodes, but they are used for a short time. Direct intrauterine delivery of progestogens is a widely used, convenient method that provides high compliance and avoids the first-pass effect of the steroid through the liver. The LNG-IUS reduces blood loss and restores hemoglobin levels in uterine fibroids without affecting the dynamics of myomatous nodes. The effectiveness of treatment with orally administered progestogens depends on the mode of administration. With a cyclic regimen (from the 14th to the 26th day of the cycle), the effectiveness is 0-20%, with a 21-day regimen (from the 5th to the 26th day of the cycle) - 30-50%. The use of progestogens in low-dose COCs reduces symptoms by 40-50%.
  It is not recommended to use progestogen therapy in the presence of submucous uterine fibroids.
  Strength of recommendation: B (level of evidence: 2b).
  It is recommended to use gonadotropin-releasing hormone agonists (Gn-RH agonists) as preoperative treatment for patients with uterine fibroids and anemia (hemoglobin< 80 г/л), а также для уменьшения размеров миомы для облегчения выполнения оперативного вмешательства или при невозможности выполнения операции эндоскопически или трансвагинально. Длительность предоперационного лечения ограничивается 3 мес .
  Strength of recommendation: A (level of evidence: 1a).
  Comments. AGn-RH are one of the effective drugs that can not only reduce the symptoms caused by uterine fibroids, but also temporarily affect the volume of myomatous nodes, while, unfortunately, the duration of treatment is limited to 6 months due to side effects (hypoestrogenism, loss of mineral density bone tissue) and are mainly used as a method of preoperative preparation. Add-back therapy (support therapy) with estrogens in adequate doses does not have a significant effect on the symptoms associated with fibroids and its volume during GnRH therapy.
  The use of progesterone antagonists (mifepristone) for the conservative treatment of uterine fibroids is not recommended.
  Strength of recommendation: C (level of evidence: 4).
  Comments. Mifepristone has an antiproliferative and proapoptotic effect against leiomyomas, and after cessation of treatment, the regrowth of myomatous nodes is less pronounced than after GnRH therapy. For uterine fibroids, the registered dose of mifepristone is 50.0 mg. However, this dose, which, according to the instructions for use of the drug, must be taken daily, for a long time, often leads to endometrial hyperplasia and causes menometrorrhagia. In addition, the reduction in the size of uterine fibroid nodes is insignificant, which, together with the hyperplastic process and bleeding, currently limits the use of this drug.
  It is recommended to use ulipristal acetate (selective progesterone receptor modulator) as a drug therapy for uterine fibroids for preoperative treatment of moderate and severe symptoms of uterine leiomyoma (primarily uterine bleeding) and as monotherapy for 3 months. , if necessary, after 2 months. Repeated course within 3 months. In women of reproductive age over 18 years of age. Monotherapy with ulipristal acetate may prevent the need for surgery.

  Comments. Ulipristal acetate affects the size of the myomatous node (reduces it) without producing side hypoestrogenic effects. Stopping bleeding is of great positive importance, which is especially important for anemia due to menometrorrhagia. Ulipristal acetate induces benign histological changes in the endometrium, which disappear after completion of therapy. Take 1 tablet of 5 mg per day for 12 weeks. Treatment with ulipristal acetate leads to a decrease in menometrorrhagia within the first 7-10 days of therapy and, often, amenorrhea. Resumption of the normal menstrual cycle usually occurs within 4 weeks. After completing the course of treatment. It is possible to conduct several courses with a break of 2 months. 10%%.
  3.2 Surgical treatment.
  Surgical treatment of uterine fibroids is recommended for heavy menstrual bleeding leading to anemia; chronic pelvic pain, which significantly reduces the quality of life; disruption of the normal functioning of internal organs adjacent to the uterus (rectum, bladder, ureters); large tumor size (more than 12 weeks of the pregnant uterus); rapid tumor growth (increase by more than 4 weeks of pregnancy within 1 year); tumor growth in postmenopause; submucosal location of the fibroid node; interligamentous and low (cervical and isthmus) location of fibroid nodes; reproductive dysfunction; infertility in the absence of other reasons.
  Strength of recommendation: A (level of evidence: 1a).
  Comments. Most patients with uterine fibroids require surgical treatment. Surgical treatment is performed as planned in the first phase of the menstrual cycle (days 5-14). If hemostasis is necessary, fibrinogen-thrombin local hemostatic agents should be used. The most successful methods of preventing adhesions are considered to be barrier methods (mesh, gels, solutions), which provide temporary delimitation of the wound from the adjacent anatomical structures.
  It is recommended to perform an emergency operation in case of spontaneous expulsion (“birth”) of a submucosal myomatous node, in case of degenerative changes in the tumor due to circulatory disorders, accompanied by signs of infection and the appearance of symptoms of an “acute abdomen”, if the ongoing antibacterial and anti-inflammatory therapy is ineffective.

  Comments. Multiple small uterine fibroids that do not cause symptoms are not an indication for surgery.
  It is recommended to perform organ-sparing surgery - myomectomy - for young women, as well as for those who wish to preserve the uterus and/or reproductive function. Indications for myomectomy are also infertility or miscarriage in the absence of any other reasons other than uterine fibroids. .
  Strength of recommendation: B (level of evidence: 2a).
  Comments. The only method of surgical treatment that leads to a complete cure (radical) is a total hysterectomy - hysterectomy. Subtotal hysterectomy (supravaginal amputation of the uterus) is not a completely radical intervention, but it can be performed after confirmation of the condition of the cervix (colposcopy, biopsy if indicated). When combined with adenomyosis, given the absence of a clear boundary of the disease, supravaginal amputation is not recommended, since incomplete removal of the above pathological processes is possible, which in the future may be the reason for another operation (removal of the stump of the cervix and other pelvic organs - the distal ureter), since this is a more complex intervention due to the development of adhesive-scarring processes involving the bladder. And although relapses of fibroids in the cervical stump occur rarely, in 15-20% of patients after surgery of this volume, cyclic bleeding from the genital tract is observed, which indicates incomplete removal of myometrial and endometrial tissue.
  It is recommended to remove submucosal myomatous nodes not exceeding 5-6 cm in diameter hysteroscopically using a mono- or bipolar resectoscope or an intrauterine morcellator.
  Strength of recommendation: B (level of evidence: 2b).
  Comments. If it is technically impossible to completely remove the node, a two-stage operation is indicated. During the 3-month break between stages, the patient is prescribed GnRH therapy, which promotes shrinkage of the uterus and migration of unremoved remnants of the node into the uterine cavity. Hysteroscopic myomectomy may be an alternative to hysterectomy in postmenopausal women in whom, due to contraction of the uterus, myomatous nodes located next to the cavity migrate into it. In premenopausal women who are not interested in preserving reproductive function, it is advisable to combine hysteroscopic myomectomy with endometrial resection.
  It is recommended to perform laparoscopic myomectomy in patients with single myomatous nodes of subserous and interstitial localization, even if they are significant in size (up to 20 cm).
  Strength of recommendation: A (level of evidence: 1b).
  Comments. The indicated maximum diameter of the node is a conditional limit, especially with its subserous location. The same approach to choosing an access should be followed in the presence of multiple subserous fibroids.
  It is recommended to perform myomectomy through the vaginal approach in all cases of nascent or emerging submucosal tumors.
  Strength of recommendation: B (level of evidence: 2a).

Risk factors for uterine fibroids
(predisposing)Knowledge of factors
predisposition will allow you to have an idea about the etiology of fibroids
uterus and develop preventive measures. Even though we
We consider risk factors in isolation, most often they are present
combination (Table 1). The influence of many factors has previously been attributed
their influence on the level or metabolism of estrogen and progesterone, but
This relationship has been proven to be extremely complex, and most likely
there are other mechanisms involved in the education process
tumors.

It should be noted that analysis of risk factors for uterine fibroids
remains a difficult task due to the relatively small
the number of epidemiological studies conducted, and their
The results may be influenced by the fact that the prevalence
Asymptomatic cases of uterine fibroids are quite high.

The most important aspect
etiology of uterine fibroids - the initiator of tumor growth - remains
unknown, although theories of the initiation of its tumorigenesis exist.
One of them confirms that an increase in estrogen levels and
progesterone leads to an increase in mitotic activity, which
may promote the formation of fibroid nodes, increasing
probability of somatic mutations.

Another hypothesis suggests
the presence of congenital genetically determined pathology
myometrium in women with uterine fibroids, expressed in enlargement
number of RE in the myometrium. Presence of genetic predisposition
to uterine fibroids indirectly indicates ethnic and family
the nature of the disease.

In addition, the risk
The incidence of uterine fibroids is higher in nulliparous women, for whom,
perhaps a large number of anovulatory cycles is characteristic, and
also obesity with pronounced aromatization of androgens into estrone in
adipose tissue. According to one hypothesis, the fundamental role in
Estrogens play a role in the pathogenesis of uterine fibroids.

This hypothesis is confirmed
clinical trials evaluating the effectiveness of fibroid treatment
uterus with gonadotropin-releasing hormone (GnRH) agonists, against the background
therapy, hypoestrogenemia accompanied by regression was observed
myomatous nodes. However, talking about fundamental
the importance of estrogens regardless of progesterone is impossible, since
the content of progesterone in the blood, like estrogens, is cyclical
changes during reproductive age, and also significantly
increased during pregnancy and decreased after menopause.

Table
1

Risk factors associated with the development of fibroids

Early menarche	Increases	Marshalletal. 1988a
Lack of childbirth medical history		Parazzinietal. 1996a
Age (late reproductive period)		Marshalletal. 1997
Obesity		Rossetal. 1986
African American race		Bairdetal. 1998
Taking tamoxifen		Deligdisch, 2000
High parity		Lumbiganonetal, 1996
Menopause		Samadietal, 1996
		Parazzinietal, 1996b
Taking COCs		Marshalletal, 1998a
Hormone therapy		Schwartzetal, 1996
Nutritional factors		Chiaffarinoetal, 1999
Foreign estrogens		Saxenaetal, 1987
Geographical factor		EzemandOtubu, 1981

Classification (ICD-10)

About 00.0	Abdominal (abdominal) pregnancy.
O 00.1	Pipe pregnancy. (1) Pregnancy in the fallopian tube. (2) Rupture of the fallopian tube due to pregnancy. (3) Tubal abortion.
O 00.2	Ovarian pregnancy.
About 00.8	Other forms ectopic pregnancy. (1) Cervical. (2) In the horn of the uterus. (3) Intraligamentary. (4) Wall.
About 00.9	Ectopic unspecified pregnancy.

O 08.0	Infection genital tract and pelvic organs caused by abortion, ectopic and molar pregnancy.
O 08.1	Long or massive bleeding caused by abortion, ectopic and molar pregnancy.
O 08.2	Embolism, caused by abortion, ectopic and molar pregnancy.
O 08.3	Shock caused abortion, ectopic and molar pregnancy.
O 08.4	Renal insufficiency caused by abortion, ectopic and molar pregnancy.
About 08.5	Violations metabolism caused by abortion, ectopic and molar pregnancy.
O 08.6	Damage pelvic organs and tissues caused by abortion, ectopic and molar pregnancy.
About 08.7	Other venous complications caused by abortion, ectopic and molar pregnancy.
About 08.8	Other complications caused by abortion, ectopic and molar pregnancy.
About 08.9	Complication, caused by abortion, ectopic and molar pregnancy, unspecified.