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

Recurrence Clinical Trial

Official title:

Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186964
• Other study ID #: PS42
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: July 9, 2014
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Konya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Konya Training and Research Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication
• Pilonidal Disease
• Recurrence

Intervention

Procedure:
• tension free primary closure
tension free primary closure of the defects created by excision of the pilonidal sinus
• karydakis
the defect after excision of the pilonidal sinus is closed by Karydakis procedure
• Limberg flap
defect after excision of the pilonidal sinus is closed by Limberg flap procedure

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	recurrence rates two years after the surgery	2 years	No