Comparison of Bascom Cleft Lift Technique Versus Limberg Flap Closure for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Controlled Trial Evaluating for Patient Satisfaction and Early Recurrence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of life and postoperative pain
研究概览
简要总结
A pilonidal sinus is a cyst on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. Limberg Flap technique is frequently used technique for this disease all over the world. However, Bascom Cleft Lift Technique is relatively newer technique. The purpose of this prospective randomized study is comparison of these techniques about patient satisfaction for postoperative period.
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
- Single (Participant)
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
- •All types of pilonidal sinus or cyst
- •The patient understands trial information and is capable of making a decision for informed consent after having received information.
- •The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial.
排除标准
- •acute abscess formation (Cruse-Foord Class IV)
- •patient with minor inflammation are included to trial after two-week antibiotic treatment (Cruse-Foord Class III)
结局指标
主要结局
Quality of life and postoperative pain
时间窗: within 30 days
Determine patient satisfaction factors using the quality of life survey (SF-36 form) on the 10th-30th day and postoperative pain by using post-operative visual analog pain scale on the 2nd-10th day
次要结局
- early recurrence rate(up to 6 months)
- Healing time(within 30 days)
- operative time(during surgical procedure (day 1))
- hospital stay(during first week (one week))