Recurrence Clinical Trial
Official title:
Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Konya Training and Research Hospital | Konya |
Lead Sponsor | Collaborator |
---|---|
Konya Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recurrence | recurrence rates two years after the surgery | 2 years | No |
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