Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

NCT07352761 | Recruiting

• 1 other identifier: Alexandria University, OBGYN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Fibroids; Laparoscopic myomectomy; Blood loss; Uterine artery occlusion; Ovarian reserve

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss

  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

  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 Outcomes (4)

• Operative time of uterine artery occlusion

  Time lapsed from intraperitoneal laparoscopic entry till completion of bilateral uterine artery occlusion (in minutes)

• Total operative time

  Time lapsed from intraperitoneal laparoscopic entry till completion of the myomectomy procedure and abdominal exit (in minutes)

• Impact on ovarian reserve

  3 months postoperatively

• Intraoperative complications

  40 minutes, 90 minutes, 120 minutes Intraoperative and 24 hours, 48 hours, 7 days Postoperatively

Study Arms (4)

Temporary clipping of uterine arteries

ACTIVE COMPARATOR

Procedure: Temporary clipping of uterine artery

Temporary occlusive suturing of uterine artery

ACTIVE COMPARATOR

Procedure: Temporary occlusive suturing of uterine artery

Bipolar coagulation of uterine arteries

ACTIVE COMPARATOR

Procedure: Bipolar coagulation of uterine arteries

No occlusion of uterine artery

ACTIVE COMPARATOR

Procedure: Laparoscopic myomectomy only

Interventions

Temporary occlusive suturing of uterine artery PROCEDURE

A "Shoelace" suture will be applied to both uterine arteries and the sutures will be removed at the end of the myomectomy procdure

Temporary occlusive suturing of uterine artery

Temporary clipping of uterine artery PROCEDURE

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

Temporary clipping of uterine arteries

Bipolar coagulation of uterine arteries PROCEDURE

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

Bipolar coagulation of uterine arteries

Laparoscopic myomectomy only PROCEDURE

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

No occlusion of uterine artery

Eligibility Criteria

• Gender Eligibility Details: Self-identified females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

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

Alexandria, El-Shatby, 21723, Egypt

RECRUITING

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

Alexandria, Smouha, Egypt

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Blood Loss, Surgical; Hemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Central Study Contacts

Ahmed Shoukry, MD/PhD

CONTACT

0201024586399; a_shokry17@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 20, 2026
• Study Start: May 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)