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NCT Number: NCT07352761

Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

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.

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Key information

Conditions

Uterine Fibroids (Leiomyoma) Blood Loss, Surgical Hemorrhage Intraoperative Complications Leiomyoma Myomectomy Myomectomy; Surgical Blood Loss Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Faculty of Medicine, Alexandria Univeristy, Alexandria, El-Shatby, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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

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

Laparoscopic myomectomy only

Procedure

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Impact on ovarian reserve

    Time frame: 3 months postoperatively

    Serum AMH will be measured 3 months postoperative and compared with the preoperative level

  4. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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