跳至主要内容
临床试验/NCT00988975
NCT00988975Unknown不适用

Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?

Urogynecology Associates, Indiana4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
4
主要终点
Anatomic success of rectocele repair

研究概览

简要总结

Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

排除标准

  • concomitant colo-rectal procedure
  • allergy to pork
  • any contraindication to laparoscopic sacrocolpopexy

结局指标

主要结局

Anatomic success of rectocele repair

时间窗: 6 months

次要结局

  • change in patient symptomatology post-operatively(6 months)

研究者

发起方
Urogynecology Associates, Indiana
申办方类型
Other

研究点 (4)

Loading locations...

相似试验