Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

January 13, 2026 updated by: Alexandria University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Shatby
      • Alexandria, El-Shatby, Egypt, 21723
    • Smouha
      • Alexandria, Smouha, Egypt
        • Recruiting
        • • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women with uterine fibroids and complaining of either abnormal uterine bleeding, infertility, urinary or rectosigmoid pressure manifestations.
  • Fibroid size from 3 - 10 cm in diameter and with
  • a maximum number of 3 fibroids.

Exclusion Criteria:

  • contraindication to pneumoperitoneum and laparoscopy,
  • patients with BMI > 30 kg/m2,
  • history of midline abdominal incisions,
  • women with history of prior ovarian surgery,
  • women with history of hormonal treatment for the last 3 months before surgery,
  • women who are not good candidate for myomectomy and who would benefit more from hysterectomy such as, women with multiple ≥ 4 leiomyomata, associated adenomyosis, recurrent fibroids after myomectomy.
  • suspected endometrial malignancy or suspected leiomyosarcoma features on ultrasound and/or MRI.
  • Submucous fibroids who will undergo hysteroscopic myomectomy beside the laparoscopic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Temporary clipping of uterine arteries
Procedure: Temporary clipping of uterine artery
Both uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure
Active Comparator: Temporary occlusive suturing of uterine artery
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
Active Comparator: Bipolar coagulation of uterine arteries
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
Active Comparator: No occlusion of uterine artery
Procedure: Laparoscopic myomectomy only
No occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: Within 40 minutes of end of the myomectomy procedure
The amount of intraoperative blood loss measured at the end of the procedure by estimation of the total volume of fluid in the suction machine.
Within 40 minutes of end of the myomectomy procedure
Postoperative Hemoglobin shift
Time Frame: 24 hours after the procedure
Postoperative hemoglobin level will be measured 24 hours after the procedure and the shift in hemoglobin from the preoperative level will be recorded
24 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time of uterine artery occlusion
Time Frame: Time lapsed from intraperitoneal laparoscopic entry till completion of bilateral uterine artery occlusion (in minutes)
Duration from accessing the retroperitoneum to occlusion of both uterine arteries
Time lapsed from intraperitoneal laparoscopic entry till completion of bilateral uterine artery occlusion (in minutes)
Total operative time
Time Frame: Time lapsed from intraperitoneal laparoscopic entry till completion of the myomectomy procedure and abdominal exit (in minutes)
The total time lapse from the peritoneal entry till the end of the myomectomy procedure
Time lapsed from intraperitoneal laparoscopic entry till completion of the myomectomy procedure and abdominal exit (in minutes)
Impact on ovarian reserve
Time Frame: 3 months postoperatively
Serum AMH will be measured 3 months postoperative and compared with the preoperative level
3 months postoperatively
Intraoperative complications
Time Frame: 40 minutes, 90 minutes, 120 minutes Intraoperative and 24 hours, 48 hours, 7 days Postoperatively
The incidence of any intraoperative complications such as, blood transfusion, vascular injury, bowel injury, conversion to laparotomy, conversion to hysterectomy will be recorded in the four study arms.
40 minutes, 90 minutes, 120 minutes Intraoperative and 24 hours, 48 hours, 7 days Postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alexandria University, OBGYN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myomectomy

Clinical Trials on Temporary clipping of uterine artery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe