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

Not Applicable

Completed

• Conditions: Pilonidal Disease; Complication; Recurrence
• Interventions: Procedure: tension free primary closure; Procedure: karydakis; Procedure: Limberg flap

• Registration Number: NCT02186964
• Lead Sponsor: Konya Meram State Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-08
• Study Completion: 2014-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tension free primary closure	tension free primary closure	patients treated by tension free primary closure
karydakis	karydakis	patients treated by Karydakis method
Limberg flap	Limberg flap	patients treated by Limberg flap procedure

Primary Outcome Measures

Name	Time	Method
recurrence	2 years	recurrence rates two years after the surgery

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey