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Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Primary Purpose

Recurrent Pilonidal Sinus Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Limberg flap
Karydakis procedure
Sponsored by
Adana Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pilonidal Sinus Disease focused on measuring Karydakis procedure, Limberg flap, recurrent pilonidal sinus

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

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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

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Limberg flap

    Karydakis procedure

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2014
    Last Updated
    November 7, 2014
    Sponsor
    Adana Numune Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02287935
    Brief Title
    Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
    Official Title
    Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Adana Numune Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Pilonidal Sinus Disease
    Keywords
    Karydakis procedure, Limberg flap, recurrent pilonidal sinus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Limberg flap
    Arm Type
    Active Comparator
    Arm Description
    Patients were divided into two groups, group 1 were treated with Limberg flap technique
    Arm Title
    Karydakis procedure
    Arm Type
    Active Comparator
    Arm Description
    Patients were divided into two groups, group 2 were treated with Karydakis procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Limberg flap
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Karydakis procedure
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease
    Description
    Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration.
    Time Frame
    January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients willing to give written informed consent 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: 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 -

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26039952
    Citation
    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.
    Results Reference
    derived

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    Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

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