Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Umeå University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
County Council of Norrbotten, Sweden
County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND)
Information provided by (Responsible Party):
Markku Haapamaki, Umeå University
ClinicalTrials.gov Identifier:
NCT00412659
First received: December 15, 2006
Last updated: October 26, 2011
Last verified: October 2011

December 15, 2006
October 26, 2011
March 2006
December 2012   (final data collection date for primary outcome measure)
time to complete wound healing [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]
  • time to complete wound healing
  • postoperative wound infection rate
  • recurrence rate
Complete list of historical versions of study NCT00412659 on ClinicalTrials.gov Archive Site
  • health-related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
  • time needed returning to normal physical activity after operation [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]
  • days spent on sick-leave [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]
  • health care costs and total costs [ Time Frame: one year ] [ Designated as safety issue: No ]
  • postoperative wound infection rate [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]
  • recurrence rate [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]
  • health-related quality of life
  • time needed returning to normal physical activity after operation
  • days spent on sick-leave
  • health care costs and total costs including sick-leave
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pilonidal Sinus
  • 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.
  • Active Comparator: Midline excision
    Midline excision for pilonidal sinus disease.
    Intervention: Procedure: Surgery for pilonidal disease, midline excision
  • Active Comparator: Karydakis
    Karydakis operation for pilonidal sinus disease.
    Intervention: Procedure: Surgery for pilonidal disease, Karydakis operation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
Not Provided
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Markku M Haapamaki, MD, PhD +46-907852013 markku.haapamaki@surgery.umu.se
Contact: Michael Dahlberg, MD, PhD +44 920 282735 michael.dahlberg@nll.se
Sweden
 
NCT00412659
PSIN-05-178M
Not Provided
Markku Haapamaki, Umeå University
Umeå University
  • County Council of Norrbotten, Sweden
  • County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND)
Principal Investigator: Christoffer Odensten, MD County Council of Norrbotten, Sweden
Principal Investigator: Markku M Haapamaki, MD, PhD Umeå University
Study Chair: Peter Naredi, MD, Ph D Umeå University
Study Director: Michael Dahlberg, MD, PhD County Council of Norrbotten
Umeå University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP