跳至主要内容
临床试验/NCT04880239
NCT04880239进行中(未招募)不适用

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

Northwestern University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月23日最近更新:
适应症
干预措施

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

Active Comparator

干预措施: Posterior colpoperineorrhaphy (Procedure)

Sacralcolpopexy without posterior colpoperineorrhaphy

No Intervention

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

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

Julia Geynisman-Tan

Director of Research; Assistant Professor

Northwestern University

研究点 (1)

Loading locations...

相似试验