To compare the efficacy of Intramyometrial Vasopressin plus Rectal Misoprostol with Intramyometrial Vasopressin alone to decrease blood loss during Laparoscopic Myomectomy: A Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss in vasopressin plus misoprostol group versus only vasopressin group.
研究概览
简要总结
Uterineleiomyomas are the most common benign tumors of the uterus in women ofreproductive age group, with a cumulative incidence of 70%. Symptomatic fibroids can b treated either by medical or surgical management. Fibroidsare the leading indication for hysterectomy worldwide. Myomectomy,however, remains the gold standard for symptomatic women who desire uterinepreservation. A major problem that myomectomy poses is excessiveblood loss from the increased uterine vasculature. Anumber of interventions have been used to decrease the blood loss duringmyomectomy. Signiï¬cantreductions in blood loss with misoprostol, vasopressin, bupivacaine plus epinephrine,tranexamic acid, pericervical tourniquet and gelatin-thrombin matrix have beendemonstrated in various clinical trials. InIndia, no studies have been conducted to compare the efficacy of differentcombination regimens to control haemorrhage during laparoscopic myomectomy.Thus, we proposed to investigate the efficacy of a single preoperative dose ofper rectal misoprostol along with intramyometrial vasopressin overintramyometrial vasopressin alone to decrease blood loss in patients undergoinglaparoscopic myomectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Women between 16-45 years of age 2.Myomatous uterus corresponding to 28 weeks size or less 3.Largest fibroid less than 15 cm 4.Haemoglobin level equal to or greater than 9 g/dL 5.No contraindication to use of vasopressin or misoprostol (renal/heart disease).
排除标准
- •1.Previous myomectomy 2.Significant medical condition such as heart, renal or pulmonary disease 3.Hb < 9 g/dL 4.Pregnancy 5.History of any bleeding disorder 6.Concurrent anticoagulation therapy 7.Grade 0 submucosal fibroid 8.Patient not fit for laparoscopic surgery.
结局指标
主要结局
Intraoperative blood loss in vasopressin plus misoprostol group versus only vasopressin group.
时间窗: Measured immediately after the end of surgery
次要结局
- Intraoperative:(1.Ease of myoma separation/enucleation)
