NCT07352761

Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

Comparing Different Techniques of Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The current study is a multiple-arm, single blinded, and controlled randomized trial. It will be conducted in two gynecological endoscopy centers: • ElShatby University Hospital, a tertiary level hospital in Alexandria, Egypt. • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt. Patient selection: women with uterine leiomyomata and planning for laparoscopic myomectomy will be assessed for eligibility then will be enrolled in the trial according to the following inclusion and exclusion criteria, after providing a written informed consent of participation. Outcome variables of the study: The primary outcome is intraoperative blood loss and the change in postoperative hemoglobin. The secondary outcomes of this study are the operative time of performing uterine arteries occlusion and the postoperative ovarian reserve.

Detailed description

The goal of this clinical trial is to evaluate the safety and impact on ovarian reserve of different techniques of bilateral uterine artery occlusion in women in the reproductive age group scheduled for laparoscopic myomectomy. The main question\[s\] it aims to answer \[is/are\]:Do the different techniques for laparoscopic uterine artery occlusion prior to myomectomy decrease the intraoperative blood loss and the postoperative hemoglobin? The investigator intends to compare three different techniques for laparoscopic uterine artery occlusion (clipping, temporary suture, and coagulation) versus control group (no occlusion of uterine arteries) to see the effect on intraoperative blood loss, postoperative hemoglobin, and impact on ovarian reserve. Participants will be randomly allocated into one of the following study arms: \* ARM 1: Will undergo temporary clipping of both uterine arteries before laparoscopic myomectomy (LAP-M). \* ARM 2: Will undergo temporary occlusion of both uterine arteries using the Shoe-lace suture technique before LAP-M. \* ARM 3: Will undergo permanent occlusion of both uterine arteries using bipolar coagulation before LAP-M. \* ARM 4 (Control group): Will undergo only LAP-M without occlusion of uterine arteries.

Conditions

• Uterine Fibroids (Leiomyoma)
• Myomectomy
• Myomectomy; Surgical Blood Loss

Interventions

Type	Name	Description
PROCEDURE	Temporary clipping of uterine artery	Both uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure
PROCEDURE	Temporary occlusive suturing of uterine artery	A "Shoelace" suture will be applied to both uterine arteries and the sutures will be removed at the end of the myomectomy procdure
PROCEDURE	Bipolar coagulation of uterine arteries	Permanent coagulation of both uterine arteries will be performed by Bipolar forceps before the start of the myomectomy procedure
PROCEDURE	Laparoscopic myomectomy only	No occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-01-31
• Completion: 2026-02-28
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

2 sites across 1 country: Egypt