Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Overview

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.

Full Title of Study: “Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2013

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.

Interventions

  • Procedure: Limberg flap
    • 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
  • Procedure: Karydakis procedure
    • 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

Arms, Groups and Cohorts

  • Active Comparator: Limberg flap
    • Patients were divided into two groups, group 1 were treated with Limberg flap technique
  • Active Comparator: Karydakis procedure
    • Patients were divided into two groups, group 2 were treated with Karydakis procedure

Clinical Trial Outcome Measures

Primary Measures

  • Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Patients willing to give written informed consent 2. 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:

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 -

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Adana Numune Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mehmet Aziret, Doc. Dr. Selim Sözen, A. Prof. Dr. İlhan Bali – Adana Numune Training and Research Hospital

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