Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recurrent fistula in ano
研究概览
简要总结
In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.
详细描述
In this prospective, randomized trail, patients are treated in case of fistula-in-ano with non-cutting seton placement. They are then randomized 1:1 in either Group A (duration of placed seton for 4 weeks) or Group B (duration of placed seton for 12 weeks). Patients are participating after informed consent is obtained.
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
盲法说明
Masking is not possible due to study design.
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient with FIA and treatment with non-cutting seton placement in our institution
- •regardless of underlying diagnoses
- •age 0-18 years
排除标准
- 未提供
研究组 & 干预措施
Group 4weeks
Duration of placed seton 4 weeks
干预措施: placement of non-cutting seton (silicone) (Procedure)
Group 12weeks
Duration of placed seton 12 weeks
干预措施: placement of non-cutting seton (silicone) (Procedure)
结局指标
主要结局
Recurrent fistula in ano
时间窗: 6 months after initial surgery
Recurrent perianal abscess
时间窗: 6 months after initial surgery
次要结局
未报告次要终点
研究者
Dr. med. Sonja Diez
Medical Doctor
Friedrich-Alexander-Universität Erlangen-Nürnberg