Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

Phase 2

Completed

• Conditions: Pilonidal Sinus
• Interventions: Procedure: Surgery for pilonidal disease, midline excision; Procedure: Surgery for pilonidal disease, Karydakis operation

• Registration Number: NCT00412659
• Lead Sponsor: Umeå University

Brief 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-12-15
• Study First Submitted QC: 2006-12-15
• Study First Posted: 2006-12-18
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Age 18 years or older.
• Surgery is considered the best available treatment.
• The patient understands trial information and is capable of making a decision for informed consent after having received information.
• The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial.

Exclusion Criteria

• Patient has had a pilonidal abscess during the last four weeks before the planned day of surgery
• Patient has had surgery (excision) for pilonidal sinus more than once before.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midline excision	Surgery for pilonidal disease, midline excision	Midline excision for pilonidal sinus disease.
Karydakis	Surgery for pilonidal disease, Karydakis operation	Karydakis operation for pilonidal sinus disease.

Primary Outcome Measures

Name	Time	Method
time to complete wound healing	one year or until reoperation

Secondary Outcome Measures

Name	Time	Method
health-related quality of life	one year
recurrence rate	one year or until reoperation
days spent on sick-leave	one year or until reoperation
postoperative wound infection rate	one year or until reoperation
time needed returning to normal physical activity after operation	one year or until reoperation
health care costs and total costs	one year

Trial Locations

Locations (2)

Sunderby Regional Hospital; 🇸🇪 Luleå, Sweden

Umeå University Hospital; 🇸🇪 Umeå, Sweden