NCT01044589终止不适用
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Massarat Zutshi2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
研究概览
简要总结
The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.
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
- •Age 18 years or older
- •fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
- •Fecal incontinence severity score of 10 or more
- •Fecal incontinence episodes of 4 or more over a 2 week period
排除标准
- •History of diabetes
- •History of allergy to porcine derivatives
- •History of infection in the anal area (abscess, fistula)
- •History of inflammatory bowel disease
- •History of hidradenitis suppurativa
- •History of immunosuppression
- •History of HIV positivity
- •History of radiation to the study site within the last 12 months
- •Patients who cannot travel to keep follow up appointments
- •Patients who are prisoners
- •Patients who are mentally handicapped
- •Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
- •Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
- •Patients with a FIQL baseline score of ≤ 4
- •Patients participating in another clinical trial for the same indication
- •Patients unwilling to give informed consent
研究组 & 干预措施
Biodesign Tissue Repair Graft
Experimental
Biodesign Tissue Repair Graft
干预措施: Biodesign Tissue Repair Graft (Device)
Biodesign Tissue Repair Graft
Experimental
Biodesign Tissue Repair Graft
干预措施: Overlapping Sphincter Repair (Other)
Overlapping Sphincter Repair
Active Comparator
Control
干预措施: Overlapping Sphincter Repair (Other)
结局指标
主要结局
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
时间窗: 12 months
次要结局
- Number of Participants Reporting a Decrease in Incontinence Episodes Per Week(24 months)
研究者
Massarat Zutshi
Staff
The Cleveland Clinic
研究点 (2)
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