Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

July 12, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • El-Shatby
      • Alexandria, El-Shatby, Egypt, 21723
        • Department of Obstetrics and Gynecology, Faculty of Medicine, Alexandria Univeristy
    • Smouha
      • Alexandria, Smouha, Egypt
        • • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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