Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Complete healing
研究概览
简要总结
This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.
详细描述
This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)
Group A: excision and paramedian closure according to modified Karydakis technique
Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pilonidal cyst requiring surgery
- •Signed Informed Consent Form
排除标准
- •Abnormal lesions
- •Injuries requiring a closing with rotation flap
结局指标
主要结局
Complete healing
时间窗: 3 weeks
percentage of complete healing
次要结局
- percentage of relapse(12 months)
- Time to recovery(12 months)
研究者
Dimitri Christoforidis
Vice-Chief in Surgery
Ente Ospedaliero Cantonale, Bellinzona