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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02186964
Other study ID # PS42
Secondary ID
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


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
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