Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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

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Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midline excision

Midline excision for pilonidal sinus disease.

Group Type ACTIVE_COMPARATOR

Surgery for pilonidal disease, midline excision

Intervention Type PROCEDURE

A midline excision is made for the treatment of pilonidal sinus disease.

Karydakis

Karydakis operation for pilonidal sinus disease.

Group Type ACTIVE_COMPARATOR

Surgery for pilonidal disease, Karydakis operation

Intervention Type PROCEDURE

A Karydakis operation is done for the treatment of pilonidal sinus disease.

Interventions

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Surgery for pilonidal disease, midline excision

A midline excision is made for the treatment of pilonidal sinus disease.

Intervention Type PROCEDURE

Surgery for pilonidal disease, Karydakis operation

A Karydakis operation is done for the treatment of pilonidal sinus disease.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No