Prospective Evaluation of Feasibility and Results of the Treatment of Pilonidal Sinus by Excision and Covering of the Defect With a Limberg-flap.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure
研究概览
简要总结
The investigators think, that the treatment of pilonidal sinus with excision and covering of the defect with a Limberg-flap is a very good treatment option. The investigators are introducing this treatment for recurrences of this illness in our clinic and want to analyse the feasibility, the results, the complications and the patients opinion after the treatment.
If the results are good, a prospective randomised study is a further option.
详细描述
- Patients, that come to our clinic with problems caused by a pilonidal sinus are informed about the different treatment options of the illness.
- If the patient suffers of a recurrence of the illness, a complete excision, followed by a covering of the defect with a Limberg-flap is recommended.
- If the patient has the first time problems by a pilonidal sinus, we recommend an open limited excision of the fistulas.
- In cases with acute infected situation, we first conduct a very limited incision/excision and treat them with antibiotics. The treatments mentioned before are in such cases offered 3 to 4 Weeks after the fist little operation.
- All Patients, that wish their pilonidal sinus treated with a complete excision followed by a covering of the defect with a Limberg-flap, are asked if they are willing to participate in the observational study.
- Patients, who gave their informed consent for the operation and the study are included.
- Preoperative data are recorded.
- The patients are operated on and intraoperative data (e.g. how big was the flap) are recorded.
- After 3 Weeks the patients are checked and complications, happiness and duration of the time off work are recorded.
- After a year the patients are contacted by sending them a postal questionnaire, which they send back to us. Additionally the are contacted by phone. Recurrence, other complications and their opinion concerning the treatment and its consequences are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Recurrence or persistence of a pilonidal sinus
- •Elective Limberg-flap operation
- •Written informed consent of the patient for the operation and participation of the study
排除标准
- •Doubts of the capability of the patient to understand the study or to decide.
研究组 & 干预措施
Pilonidal Sinus T. With Limberg F.
All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
干预措施: Limberg-flap (Procedure)
结局指标
主要结局
Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure
时间窗: 1 year
At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.
次要结局
- Cosmetic Score(1 year)
- Body Image Score(1 year)
- Reoperations Needed for Treatment of Complication(1year)
- Minor Complications (Wound Complications)(1 year)
- Patient Overall Satisfaction With Procedure(1 year)