Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Study Overview
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Brief Summary
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It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Detailed Description
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Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery. It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Official Title
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Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Conditions
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Recurrent Pilonidal Sinus Disease

Intervention / Treatment
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* Procedure: Limberg flap
* Procedure: Karydakis procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to give written informed consent There should be recurrent pilonidal sinus 2. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus 3. International normalizing ratio (INR) less than 1.5 4. Prothrombin time (PT) should be less than 15 s 5. Partial thromboplastin (PTT) time should be near normal 6. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding 7. There must be no infection at the time of surgery - Exclusion Criteria: Patients not willing to give informed consent Age less than 16 years Patient presenting with conditions mimicking pilonidal sinus Diabetes mellitus, renal failure, immunosuppression e.g. were excluded -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Limberg flap<br>Patients were divided into two groups, group 1 were treated with Limberg flap technique | Procedure: Limberg flap<br>* Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions<br>|
| Active Comparator: Karydakis procedure<br>Patients were divided into two groups, group 2 were treated with Karydakis procedure | Procedure: Karydakis procedure<br>* Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease | Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration. | January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals | 

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