NCT00412659

Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.

Detailed description

Excision in the midline and primary suture is a long proven method of treating pilonidal sinus. However it's associated with high incidence of post operative infection and recurrence. On the other hand Karydakis operation (excision lateral of the midline, transposition flap and primary suture) is just a slightly more complicated procedure but has five times less recurrences reported in case series. The purpose of the present study is to compare the surgical results and costs of the two surgical methods utilized. In addition the investigators aim to compare the quality of life at defined time points after surgery. Eligible patients are randomized to two groups of surgeons, well trained in either the midline operation or the Karydakis operation (expertise based design). The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached. Comparison: Midline excision andd primary suture compared with the Karydakis operation (excision lateral of the midline and primary suture) for pilonidal disease.

Conditions

• Pilonidal Sinus

Interventions

Type	Name	Description
PROCEDURE	Surgery for pilonidal disease, midline excision	A midline excision is made for the treatment of pilonidal sinus disease.
PROCEDURE	Surgery for pilonidal disease, Karydakis operation	A Karydakis operation is done for the treatment of pilonidal sinus disease.

Timeline

• Start date: 2006-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2006-12-18
• Last updated: 2016-06-01

Locations

2 sites across 1 country: Sweden