Impact of Level III Support Procedure on Normalization of Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Enlarged Genital Hiatus at 6 months postoperatively
研究概览
简要总结
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus.
An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.
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 (Outcomes Assessor)
盲法说明
Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.
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 subjects with pelvic organ prolapse (POP)
- •Planning a surgical repair of POP with minimally invasive sacrocolpopexy
- •Preoperative resting genital hiatus measure between 4.0 and 7.5cm
排除标准
- •subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above
- •*Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)*
结局指标
主要结局
Enlarged Genital Hiatus at 6 months postoperatively
时间窗: 6 months postoperatively
Proportion of subjects with enlarged genital hiatus on pelvic exam
次要结局
- Composite prolapse recurrence(12 months)
- Subjective prolapse recurrence(24 months)
- Sexual Function postoperatively(6, 12 months postoperatively)
- Pelvic Floor Distress Inventory Change(baseline, 6, 12 months postoperatively)
- Levator Hiatal Area(baseline, 6 months postoperatively)
- Dyspareunia postoperatively(6, 12 months postoperatively)
研究者
Stephanie Glass Clark
Assistant Professor of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences
University of Pittsburgh