Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this study is to assess the feasibility of performing prophylactic McCall culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be measuring pelvic support (using POP-Q) and sexual function before and at different time points (up to 12 months) postoperatively.
The investigators hypothesize that women undergoing the McCall culdoplasty will not have different immediate surgical outcomes (operative time, etc) and may have better pelvic support and sexual function in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-99 undergoing elective laparoscopic hysterectomy for benign indications with surgeons in the division of Advanced Laparoscopy and Pelvic Pain at UNC-Chapel Hill.
排除标准
- •Current symptomatic or asymptomatic pelvic organ prolapse as measured by the Pelvic Organ Prolapse Quantification (POPQ) system.
- •Pregnancy
- •Non-English speaking
- •Unable to provide informed consent
- •Pathology causing an obliterated cul-de-sac
结局指标
主要结局
Feasibility
时间窗: 6 months
The primary aim of the study is to generate feasibility data for performing a powered randomized trial on prophylactic modified McCall's culdoplasty during benign total laparoscopic hysterectomy. As such, we will measure operative time with the hypothesis that the intervention does not add significant additional effort. We will also collect information regarding patient willingness to participate as well as intra- and post-operative complication data.
次要结局
- Pelvic support(12 months)
- Sexual function(12 months)