Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

NCT02287935 | Completed

• 1 other identifier: AdanaNTRH
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Pilonidal Sinus Disease

Keywords

Karydakis procedure; Limberg flap; recurrent pilonidal sinus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Limberg flap

ACTIVE COMPARATOR

Patients were divided into two groups, group 1 were treated with Limberg flap technique

Procedure: Limberg flap

Karydakis procedure

ACTIVE COMPARATOR

Patients were divided into two groups, group 2 were treated with Karydakis procedure

Procedure: Karydakis procedure

Interventions

Limberg flap PROCEDURE

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

Limberg flap

Karydakis procedure 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

Karydakis procedure

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adana Numune Training and Research Hospital: lead

Related Publications (1)

• Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.

  PMID: 26039952 DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doc. Dr. Selim Sözen, A. Prof. Dr. İlhan Bali

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: November 11, 2014
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11