A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Vaginal Length
研究概览
简要总结
The purpose of this study is to evaluate the possible impacts of two techniques of vaginal cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal cuff closure and the impact that these techniques have on vaginal length, sexual function, and overall complication rates.
详细描述
A Validated questionnaire the Female Sexual Function Index (FSFI) and total vaginal lengths will be used to evaluate patients pre-operatively, at 4-6 weeks post-operatively, and 6 months post operatively. The FSFI will also be sent to the patient 12 months post operatively. These data will be used to assess sexual function and total vaginal length in patients undergoing minimally invasive hysterectomy. The study endpoint will occur after the 12 month follow-up questionnaire. Additionally, all complications following surgery will be tracked over the study period for comparison.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy
排除标准
- •Adults unable to consent
- •Children under the age of 18
- •Pregnant women
- •Post-menopausal women
- •Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
- •Patients unable to consent to the procedure in the English language
研究组 & 干预措施
Vertical Cuff
Vaginal cuff closure will be done vertically.
干预措施: Cuff Closure (Procedure)
Horizontal Cuff
Vaginal cuff closure will be done horizontally.
干预措施: Cuff Closure (Procedure)
结局指标
主要结局
Vaginal Length
时间窗: up to 4-6 weeks post-operative
The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, at 4-6 weeks postoperatively.
次要结局
- Sexual Function(Pre-operative, 6 and 12 months post-operativey)
研究者
Timothy A Deimling
Minimally Invastive GYN Surgery
Milton S. Hershey Medical Center