Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Anatomic cure defined by standardized POPQ measures
研究概览
简要总结
The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.
详细描述
Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.
Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage 2 or greater symptomatic rectocele
- •Women electing to undergo surgical rectocele repair
- •Women over age 21 years
- •Women willing to comply with study procedures and follow-up
排除标准
- •Pregnant or nursing women
- •History of porcine allergy
- •History of connective tissue disease, pelvic malignancy, or pelvic radiation
- •Women undergoing concurrent sacral colpopexy
结局指标
主要结局
Anatomic cure defined by standardized POPQ measures
时间窗: 12 months
次要结局
- Quality of life based on PFIQ validated questionnaire(12 months)
- Sexual function(12 months)
- Patient centered goals(12 months)
研究者
Vivian Sung
Principal Investigator
Women and Infants Hospital of Rhode Island