Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Fistula healing
研究概览
简要总结
The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
详细描述
Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue).
Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method.
The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group
- •Patients that are older than 18 years of age and are able to understand and sign consent
- •Patients that are suitable candidates for either seton or collagen plug placement
排除标准
- •Preoperative patient exclusion factors:
- •Pregnant patients
- •Patients with a tumor-related fistula
- •Patients with known allergies to porcine products
- •Patients with known Crohn's disease
- •Intraoperative patient exclusion factors:
- •Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery
- •Patients with a large diameter fistula (>3mm)
- •Patients with a superficial fistula
- •Patients with a short fistula (<1 cm in length)
结局指标
主要结局
Fistula healing
Treatment failure
次要结局
- Time to treatment failure
- Rates of postoperative fecal continence
- Time to fistula healing