Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Infection
研究概览
简要总结
Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have designed a comparative study between the conventional and the minimally invasive treatment. Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision with a Bascom out-midline closure (Control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic sacrococcygeal pilonidal sinus
排除标准
- •Absence of consent to the study
- •Acute abscess
研究组 & 干预措施
VAAPS group
patients undergoing video assisted ablation of pilonidal sinus
干预措施: Video assisted ablation of pilonidal sinus (Procedure)
conventional treatment group
patients undergoing conventional off-midline Bascom cleft lift procedure
干预措施: Bascom Cleft lift procedure (Procedure)
结局指标
主要结局
Infection
时间窗: at 30 days after surgery
Wound infection was defined as redness and/or oedema of the skin and/or discharge.
次要结局
- Pain(up to 30 days after surgery)
- return at work(up to 30 days after surgery)
- recurrence(at 1 year after surgery)
- satisfaction(up to six months after surgery)
研究者
Francesco Milone
Professor of Surgery
Federico II University