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Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods

Primary Purpose

Pilonidal Disease, Recurrence, Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
tension free primary closure
karydakis
Limberg flap
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • having pilonidal sinus disease
  • desire for surgical treatment
  • accept to be involved in the study

Exclusion Criteria:

  • patients under age of 18
  • recurrent cases

Sites / Locations

  • Konya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

tension free primary closure

karydakis

Limberg flap

Arm Description

patients treated by tension free primary closure

patients treated by Karydakis method

patients treated by Limberg flap procedure

Outcomes

Primary Outcome Measures

recurrence
recurrence rates two years after the surgery

Secondary Outcome Measures

Full Information

First Posted
July 8, 2014
Last Updated
July 9, 2014
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02186964
Brief Title
Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods
Official Title
Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life. There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Disease, Recurrence, Complication

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
tension free primary closure
Arm Type
Experimental
Arm Description
patients treated by tension free primary closure
Arm Title
karydakis
Arm Type
Experimental
Arm Description
patients treated by Karydakis method
Arm Title
Limberg flap
Arm Type
Experimental
Arm Description
patients treated by Limberg flap procedure
Intervention Type
Procedure
Intervention Name(s)
tension free primary closure
Intervention Description
tension free primary closure of the defects created by excision of the pilonidal sinus
Intervention Type
Procedure
Intervention Name(s)
karydakis
Intervention Description
the defect after excision of the pilonidal sinus is closed by Karydakis procedure
Intervention Type
Procedure
Intervention Name(s)
Limberg flap
Intervention Description
defect after excision of the pilonidal sinus is closed by Limberg flap procedure
Primary Outcome Measure Information:
Title
recurrence
Description
recurrence rates two years after the surgery
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: having pilonidal sinus disease desire for surgical treatment accept to be involved in the study Exclusion Criteria: patients under age of 18 recurrent cases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Karahan, Professor
Organizational Affiliation
Konya Meram State Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
ZIP/Postal Code
42180
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
26531235
Citation
Sevinc B, Karahan O, Okus A, Ay S, Aksoy N, Simsek G. Randomized prospective comparison of midline and off-midline closure techniques in pilonidal sinus surgery. Surgery. 2016 Mar;159(3):749-54. doi: 10.1016/j.surg.2015.09.024. Epub 2015 Oct 31.
Results Reference
derived

Learn more about this trial

Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods

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