ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

Study Overview
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Brief Summary
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A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.

Detailed Description
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Primary endpoints • Assess the volume of blood loss Secondary endpoints Compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length of hospital and ICU stay, and leiomyoma symptoms relief Determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach. Sixty patients will undergo laparoscopic myomectomy preceded by temporary uterine blood supply occlusion performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Sixty patients will undergo conventional laparoscopic myomectomy performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Patients eligible for inclusion, after signing an informed voluntary consent to participate in the study, will be randomized in a 1:1 ratio to the treatment groups using stratification by age, size, and leiomyoma nodes location.

Official Title
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ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

Conditions
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Uterine Leiomyoma, Uterine Fibroid, Leiomyoma, Uterine, Myoma;Uterus, Laparoscopic Myomectomy, Postoperative Complications, Blood Loss, Surgical, Fertility Issues, Pregnancy Complications

Intervention / Treatment
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* Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion
* Procedure: Conventional laparoscopic myomectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic uterine leiomyoma Size of leiomyoma node >5 cm based on imaging Leiomyoma node types 3, 4, 5, 6 according to The International Federation of Gynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removed during hysteroscopy Single or multiple nodes Absent contraindications for laparoscopic myomectomy Voluntarily signed informed consent to participate in the study Exclusion Criteria: Age < 18 years Asymptomatic uterine leiomyoma Size of leiomyoma node <5 cm based on imaging Absence of leiomyoma node types 3, 4, 5, 6 according to FIGO classification and type 2 not feasible to be removed during hysteroscopy Planned simultaneous hysteroscopy with leiomyoma node excision Current pregnancy and breastfeeding Suspicion of a malignant uterine tumor Prior uterine leiomyoma surgery Contraindications for laparoscopic myomectomy Lack of decision-making capacity hindering signing the consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic myomectomy with temporary blood supply occlusion<br>Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries. | Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion<br>* Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.<br>* Other names: Temporary uterine arteries occlusion;|
| Active Comparator: Conventional laparoscopic myomectomy<br>Laparoscopic myomectomy is performed without prior temporary blood supply occlusion. | Procedure: Conventional laparoscopic myomectomy<br>* Laparoscopic myomectomy without prior temporary uterine blood supply occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Evaluation of blood loss volume | At the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment characteristics | Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief | During 6 months since the intervention | 
| Impact on fertility | Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery | During 18 months since the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporary uterine artery occlusion, temporary uterine blood supply occlusion