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NCT Number: NCT00412659

Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sunderby Regional Hospital, Luleå, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery for pilonidal disease, midline excision

Procedure

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

Surgery for pilonidal disease, Karydakis operation

Procedure

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

Primary outcomes

  1. time to complete wound healing

    Time frame: one year or until reoperation

Secondary outcomes

  1. health-related quality of life

    Time frame: one year

  2. time needed returning to normal physical activity after operation

    Time frame: one year or until reoperation

  3. days spent on sick-leave

    Time frame: one year or until reoperation

  4. health care costs and total costs

    Time frame: one year

  5. postoperative wound infection rate

    Time frame: one year or until reoperation

  6. recurrence rate

    Time frame: one year or until reoperation

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • County Council of Norrbotten, Sweden
  • Norrlandstingens Regionförbund

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Dec 18, 2006
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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