RecruitingNot ApplicableNCT07352761

Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

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


Sponsor

Alexandria University

Enrollment

60 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches during laparoscopic fibroid removal (myomectomy): one approach blocks both uterine arteries temporarily to reduce blood loss, and one does not. Researchers want to find out if blocking the uterine arteries during the procedure leads to better outcomes, less bleeding, and good recovery. **You may be eligible if:** - You are a woman with uterine fibroids causing problems such as heavy periods, infertility, or pressure on the bladder or bowel - Your fibroids are between 3 and 10 cm in size - You have no more than 3 fibroids - You are a suitable candidate for laparoscopic (keyhole) surgery **You may NOT be eligible if:** - You have a BMI over 30 - You have had previous abdominal surgery involving a midline incision - You have had prior ovarian surgery - You have been on hormonal treatment within the past 3 months - You have 4 or more fibroids, adenomyosis, or previously recurring fibroids after myomectomy - Imaging suggests the possibility of cancer in the fibroids - You have submucosal fibroids requiring a different procedure (hysteroscopic surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETemporary clipping of uterine artery

Both uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure

PROCEDURETemporary 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

PROCEDUREBipolar coagulation of uterine arteries

Permanent coagulation of both uterine arteries will be performed by Bipolar forceps before the start of the myomectomy procedure

PROCEDURELaparoscopic myomectomy only

No occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed


Locations(2)

Department of Obstetrics and Gynecology, Faculty of Medicine, Alexandria Univeristy

Alexandria, El-Shatby, Egypt

• Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt.

Alexandria, Smouha, Egypt

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NCT07352761


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