Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

November 7, 2014 updated by: Mehmet Aziret, Adana Numune Training and Research Hospital

Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Limberg flap
Patients were divided into two groups, group 1 were treated with Limberg flap technique
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
Active Comparator: Karydakis procedure
Patients were divided into two groups, group 2 were treated with Karydakis procedure
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adana Numune Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdanaNTRH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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