A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Healing of the anal fistula
研究概览
简要总结
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
详细描述
The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy.
The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose.
This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 22 years of age or older
- •Subject is willing to comply with study related procedures
- •Subject is not pregnant
- •Subject has a transsphincteric fistula
- •Subject is medically fit to undergo LIFT
- •Subject has a draining seton for a minimum of 6 weeks
排除标准
- •Crohn's disease
- •Pelvic radiation treatment
- •Known or suspected HIV/AIDS
- •Known sensitivity to pork products
- •Abscess or fistula etiology other than cryptoglandular
- •Abdominal malignancies
- •Patients with <1 year life expectancy
- •History of smoking
- •Known anorectal dysfunction (fecal incontinence)
- •Chronic use of steroids or other agents which may affect wound healing
- •Unable to consent to study
- •Unable to complete 1 year follow up
研究组 & 干预措施
Strattice-LIFT
干预措施: Strattice-LIFT (Device)
结局指标
主要结局
Healing of the anal fistula
时间窗: 6 months
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
次要结局
- Healing of the anal fistula(1 year)
- Postoperative Pain(1 year)
- Complications(1 year)