NCT03038945已完成不适用
Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
CES University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cuff closure time
研究概览
简要总结
Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for total laparoscopic hysterectomy without other simultaneous procedures , for benign causes , who were agree to participate in the trial and give their written consent.
- •Patients ASA (American Society of Anesthesiologists) 1 and 2
- •Patients who are able to communicate by telephone and answer questions
排除标准
- •Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic obstructive pulmonary disease), collagen diseases, diabetes.
- •Endometriosis III / IV
- •Patients who can not be reached by phone
结局指标
主要结局
Cuff closure time
时间窗: 20 minutes
time spend for vaginal Cuff closure (in minutes)
次要结局
- Intra or postoperative complications(10 days)
- Dyspareunia(12 weeks)
研究者
Claudia López
Gynecologist
CES University
研究点 (1)
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