Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Fistula recurrence; New opening
研究概览
简要总结
Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.
详细描述
A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complex transsphincteric anal fistula
排除标准
- •ano/rectovaginal fistula
结局指标
主要结局
Fistula recurrence; New opening
时间窗: Through study completion, an average of 8 years
Faeces coming through external opening
Fistula recurrence; Technical failure
时间窗: Week 2
Plug fallen out
Fistula recurrence; Infection
时间窗: Through study completion, an average of 8 years
Surgical site infection
次要结局
未报告次要终点