Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods
Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedJuly 10, 2014
July 1, 2014
1.5 years
July 8, 2014
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence
recurrence rates two years after the surgery
2 years
Study Arms (3)
tension free primary closure
EXPERIMENTALpatients treated by tension free primary closure
karydakis
EXPERIMENTALpatients treated by Karydakis method
Limberg flap
EXPERIMENTALpatients treated by Limberg flap procedure
Interventions
tension free primary closure of the defects created by excision of the pilonidal sinus
the defect after excision of the pilonidal sinus is closed by Karydakis procedure
defect after excision of the pilonidal sinus is closed by Limberg flap procedure
Eligibility Criteria
You may qualify if:
- having pilonidal sinus disease
- desire for surgical treatment
- accept to be involved in the study
You may not qualify if:
- patients under age of 18
- recurrent cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konya Training and Research Hospital
Konya, 42180, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 26531235DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ömer Karahan, Professor
Konya Meram State Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 10, 2014
Study Start
February 1, 2011
Primary Completion
August 1, 2012
Study Completion
May 1, 2014
Last Updated
July 10, 2014
Record last verified: 2014-07