REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pelvic Organ Prolapse Quantification (POP-Q) System
研究概览
简要总结
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
详细描述
The decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. Based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. Experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. Others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. No randomized trials exist comparing prolapse outcomes using new, ultra-light polypropylene mesh with and without posterior colpoperineorrhaphy. The investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using Restorelle mesh with and without posterior colpoperineorrhaphy. However, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. This will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.
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)
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
- •Women over the age of 18
- •English or Spanish speaking
- •Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
- •Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm
排除标准
- •Patient has had prior prolapse surgery
- •Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)
- •Baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no)
- •Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam
- •Patient planning a concomitant Burch procedure
研究组 & 干预措施
Sacralcolpopexy with posterior colpoperineorrhaphy
干预措施: Posterior colpoperineorrhaphy (Procedure)
Sacralcolpopexy without posterior colpoperineorrhaphy
结局指标
主要结局
Pelvic Organ Prolapse Quantification (POP-Q) System
时间窗: 1 Year
The POP-Q System will be used to compare the rate of prolapse recurrence at 1 year between women undergoing a sacrocolpopexy with Restorelle mesh with and without a concomitant posterior colpoperineorrhaphy.
次要结局
- Surgical and Perioperative Events: Blood Loss(2 Weeks)
- Surgical and Perioperative Events: Operative Time(Day of surgery)
- Surgical and Perioperative Events: Postoperative Pain(2 Weeks)
- Surgical and Perioperative Events: Pain Medication Use(2 Weeks)
- Defecatory Dysfunction(1 Year)
- Dyspareunia(1 Year)
研究者
Julia Geynisman-Tan
Director of Research; Assistant Professor
Northwestern University
