Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

Alexandria University

Status: Enrolling

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

Treatments: Procedure: Temporary clipping of uterine artery; Procedure: Bipolar coagulation of uterine arteries; Procedure: Temporary occlusive suturing of uterine artery; Procedure: Laparoscopic myomectomy only

Study type: Interventional

Funder types: Other

Identifiers

NCT07352761

Alexandria University, OBGYN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Temporary clipping of uterine arteries

Active Comparator group

Treatment:

Procedure: Temporary clipping of uterine artery

Temporary occlusive suturing of uterine artery

Active Comparator group

Treatment:

Procedure: Temporary occlusive suturing of uterine artery

Bipolar coagulation of uterine arteries

Active Comparator group

Treatment:

Procedure: Bipolar coagulation of uterine arteries

No occlusion of uterine artery

Active Comparator group

Treatment:

Procedure: Laparoscopic myomectomy only