Limberg-flap: Prospective Data Collection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Evaluation of Feasibility and Results of the Treatment of Pilonidal Sinus by Excision and Covering of the Defect With a Limberg-flap.

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Procedure: Limberg-flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Doubts of the capability of the patient to understand the study or to decide.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilonidal Sinus T. With Limberg F.<br>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. | Procedure: Limberg-flap<br>* Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock<br>* Other names: Romboid-flap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Complications (Wound Complications) | All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted. | 1 year | 
| Reoperations Needed for Treatment of Complication | All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year. All reoperations that were done were assessed and measured. | 1year | 
| Patient Overall Satisfaction With Procedure | Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10. | 1 year | 
| Body Image Score | Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20. | 1 year | 
| Cosmetic Score | Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pilonidal sinus, recurrence, Limberg flap