NCT02879487已完成不适用
Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Vaginal dehiscence
研究概览
简要总结
The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All total laparoscopic hysterectomies performed by a single surgeon
- •Both benign and malignant cases
- •Completed laparoscopically
- •Intracorporeal vaginal cuff suturing
排除标准
- •Robotic hysterectomies
- •Pelvic infection within 30 days before surgery
- •Conversion to laparotomy
结局指标
主要结局
Vaginal dehiscence
时间窗: 3 months
Vaginal dehiscence up to 3 months after surgery
次要结局
未报告次要终点
研究者
研究点 (2)
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