Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).
研究概览
简要总结
Women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.
详细描述
The traditional approach to surgical repair of posterior wall defect is the posterior colporrhaphy. Although this technique has been successful in the anatomic correction of the defect, the functional outcomes have been disappointing. This fact suggests improvement in the functional and anatomic outcomes following a traditional posterior colporrhaphy. Consequently, the idea of incorporating graft material into the repair to augment the patient's own tissue has been examined. Placing a piece of graft material in between the vagina and rectum adds an extra layer of support and thus augments the strength of the repair. The purpose of this study is to evaluate the anatomic and functional outcomes of posterior compartment, graft-augmented traditional posterior colporrhaphy vs. traditional posterior colporrhaphy alone.
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 (Participant)
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
- •Age > 18 years old
- •Posterior wall defect with point Ap or Bp at 0 or greater
- •Desires surgical correction
- •Willing to accept randomization to graft vs. no graft
- •Competent to sign an informed consent
- •Completed childbearing
- •Non-pregnant
排除标准
- •Current anal sphincter disruption with planned incontinent surgical repairs
- •Poor surgical candidate
- •History of rectal cancer or inflammatory bowel disease
- •Current rectovaginal
- •History of vaginal cancer
- •History of vaginal/pelvic radiation
- •Foreshortened vagina
- •Previous adverse reaction to Xenform matrix graft material
结局指标
主要结局
The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).
时间窗: 5 Years
次要结局
- The secondary outcomes will be measuring the effects of the surgical repair on various aspects of life using a series of questionnaires: SF-36 as a measure of quality of life, PISQ to measure sexual function, and FISI to measure rectal function.(5 Years)