Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Primary Endpoint
- Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients willing to give written informed consent
- •There should be recurrent pilonidal sinus
- •Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus
- •International normalizing ratio (INR) less than 1.5
- •Prothrombin time (PT) should be less than 15 s
- •Partial thromboplastin (PTT) time should be near normal
- •Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehmet Aziret
Doc. Dr. Selim Sözen, A. Prof. Dr. İlhan Bali
Adana Numune Training and Research Hospital