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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Pilonidal Sinus

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to complete wound healing

Outcome Time Frame:

one year or until reoperation

Safety Issue:


Principal Investigator

Christoffer Odensten, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

County Council of Norrbotten, Sweden


Sweden: The National Board of Health and Welfare

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Pilonidal Sinus
  • Sinus, Pilonidal
  • Pilonidal sinus
  • Pilonidal cysts
  • Pilonidal disease
  • midline excision
  • Karydakis operation
  • expertise based study
  • surgery
  • therapy
  • Pilonidal Sinus