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

Not Applicable

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

• Registration Number: NCT04519593
• Lead Sponsor: Mother and Child Clinic Saint-Petersburg

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-19
• Study Start: 2020-09-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-14
• Primary Completion: 2022-08-31
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood loss	At the end of the intervention	Evaluation of blood loss volume

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mother and Child Clinic Saint-Petersburg; 🇷🇺 Saint Petersburg, Russian Federation