Comparing Different Techniques of Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Temporary clipping of uterine arteries
干预措施: Temporary clipping of uterine artery (Procedure)
Temporary occlusive suturing of uterine artery
干预措施: Temporary occlusive suturing of uterine artery (Procedure)
Bipolar coagulation of uterine arteries
干预措施: Bipolar coagulation of uterine arteries (Procedure)
No occlusion of uterine artery
干预措施: Laparoscopic myomectomy only (Procedure)
结局指标
主要结局
Intraoperative blood loss
时间窗: 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.
Postoperative Hemoglobin shift
时间窗: 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
次要结局
- 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)