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

• Sponsor: Konya Meram State Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02186964
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 38.9
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pilonidal Disease; Recurrence; Complication	Procedure: tension free primary closure; Procedure: karydakis; Procedure: Limberg flap	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tension free primary closure patients treated by tension free primary closure	Procedure: tension free primary closure; tension free primary closure of the defects created by excision of the pilonidal sinus
Experimental: karydakis patients treated by Karydakis method	Procedure: karydakis; the defect after excision of the pilonidal sinus is closed by Karydakis procedure
Experimental: Limberg flap patients treated by Limberg flap procedure	Procedure: Limberg flap; defect after excision of the pilonidal sinus is closed by Limberg flap procedure

Outcome Measures

Primary Outcome Measures

1. recurrence [2 years]

   recurrence rates two years after the surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konya Training and Research Hospital	Konya		Turkey	42180

Sponsors and Collaborators

• Konya Meram State Hospital

Investigators

• Study Director: Ömer Karahan, Professor, Konya Meram State Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: barış sevinç, MD, Konya Meram State Hospital
• ClinicalTrials.gov Identifier: NCT02186964
• Other Study ID Numbers: PS42
• First Posted: Jul 10, 2014
• Last Update Posted: Jul 10, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Recurrence

Study Results

No Results Posted as of Jul 10, 2014