Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Healing rate
研究概览
简要总结
Pilonidal sinus disease is a chronic acquired disease leading to significant morbidity and healthcare costs in young man and women. Despite different treatment methods, the disease relatively often leads to postoperative complications and recurrence.(8). Advantages of mini-invasive techniques include: quicker recovery and earlier return to work and high patient satisfaction. Randomized studies are rare and this applies especially to newer mini-invasive techniques. The purpose of the investigators prospective study is to randomly compare the mini-invasive laser ablation technique to the mini-invasive fibrin glue treatment in pilonidal sinus disease surgery.
详细描述
This is a multicenter study comparing two mini-invasive treatmnet options in pilonidal sinus disease. The study is carried out in four hospitals in Uusimaa county of Finland (Jorvi hospital, Porvoo hospital, Lohja hospital and Hyvinkää hospital). Patients, who are 18 or above, with a symptomatic primary pilonidal sinus disease are eligible for the study. On the day of surgery, the patient is randomly assigned to one of the two surgery groups. The main variable of our study is the healing rate at 2 months after surgery. Other variables to be studied are: postoperative complications, length of sick leave, time for returning to everyday life, recurrence rate and the effects of PSD and PSD surgery on the patient's quality of life. A cost analysis will be performed. Risk factors such as overweight, pubic hair, smoking and associated diseases such as diabetes will also be analyzed. According to the power calculation, the investigators need 94 patients in each group to ensure the success of the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary pilonidal sinus disease
- •age 18 and above
排除标准
- •recurrent pilonidal sinus disease
- •age under 18
- •inability to understand Finnish or Swedish (the questionnaires are in Finnish and Swedish only, the two official languages of Finland)
研究组 & 干预措施
study group 1
surgery + laser ablation
干预措施: surgery + laser (Procedure)
study group 2
surgery + fibrine glue
干预措施: surgery + fibrine glue (Procedure)
结局指标
主要结局
Healing rate
时间窗: 2 months after surgery
Healing rate will be assessed by a questionnaire and a phone call
Quality of life
时间窗: 2 months after surgery
Quality of life will be assessed by a questionnaire, the RAND 36-Item Health Survey
次要结局
- Postoperative complications(2 - 3 months after the surgery)
- Recurrence rate(1, 3 and 5 years after surgery)
- Cost analysis(At 2 months after surgery)
- Sick leave(2 months and 1 year after surgery)
- Recovery time(2 months and 1 year after surgery)
研究者
Kethe Hermunen
Principal Investigator
Helsinki University Central Hospital