Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Not Applicable

Completed

• Conditions: Recurrent Pilonidal Sinus Disease
• Interventions: Procedure: Limberg flap; Procedure: Karydakis procedure

• Registration Number: NCT02287935
• Lead Sponsor: Adana Numune Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-12
• Study Completion: 2014-09
• Study First Submitted: 2014-10-24
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-07
• Last Update Submitted: 2014-11-07
• Study First Posted: 2014-11-11
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Patients willing to give written informed consent

2. There should be recurrent pilonidal sinus

3. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus

4. International normalizing ratio (INR) less than 1.5

5. Prothrombin time (PT) should be less than 15 s

6. Partial thromboplastin (PTT) time should be near normal

7. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding

8. There must be no infection at the time of surgery

Exclusion Criteria

1. Patients not willing to give informed consent

2. Age less than 16 years

3. Patient presenting with conditions mimicking pilonidal sinus

4. Diabetes mellitus, renal failure, immunosuppression e.g. were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limberg flap	Limberg flap	Patients were divided into two groups, group 1 were treated with Limberg flap technique
Karydakis procedure	Karydakis procedure	Patients were divided into two groups, group 2 were treated with Karydakis procedure

Primary Outcome Measures

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