Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

Alexandria University60 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

Temporary clipping of uterine arteryPROCEDURE

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

Temporary occlusive suturing of uterine arteryPROCEDURE

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 arteriesPROCEDURE

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

Laparoscopic myomectomy onlyPROCEDURE

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 24 hours after the procedure

Secondary Outcomes

Operative time of uterine artery occlusion

Duration from accessing the retroperitoneum to occlusion of both uterine arteries

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

Total operative time

The total time lapse from the peritoneal entry till the end of the myomectomy procedure

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

Impact on ovarian reserve

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

Time frame: 3 months postoperatively

Intraoperative complications

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.

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