Prospective Study on the Incidence of Recurrence in Laser Treatment of Pilonidal Cysts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Clinical recurrence
研究概览
简要总结
The goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus.
The main question it aims to answer is:
• Is there a clinical recurrence (presence of a fistula in the intergluteal cleft) 2 years after laser treatment of pilonidal sinus? Participants who undergo surgery as part of their regular medical care will answer survey questions about recurrence at 1 and 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 requiring laser surgery for pilonidal sinus, of any type (including recurrence after radical cure or laser treatment)
- •Patient able to understand the protocol and having given written informed consent to participate in the study,
- •Patient affiliated to the social security system or entitled to it.
排除标准
- •Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
- •Patient already included in a research study
- •Patient under guardianship, conservatorship, or deprived of liberty
- •Patient under an activated future protection mandate
- •Patient under family authorization
- •Patient under judicial protection.
研究组 & 干预措施
Patients requiring laser surgery for pilonidal sinus
pilonidal sinus of any type (including recurrence after radical cure or laser treatment)
结局指标
主要结局
Clinical recurrence
时间窗: 2 years post-operatively
2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)
次要结局
未报告次要终点