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临床试验/NCT02879487
NCT02879487已完成不适用

Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial

Ankara University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年8月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

salih taskin

Assoc Prof

Ankara University

研究点 (2)

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