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Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412659
First Posted: December 18, 2006
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
County Council of Norrbotten, Sweden
Norrlandstingens Regionförbund
Information provided by (Responsible Party):
Markku Haapamaki, Umeå University
December 15, 2006
December 18, 2006
June 1, 2016
March 2006
March 2016   (Final data collection date for primary outcome measure)
time to complete wound healing [ Time Frame: one year or until reoperation ]
  • 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 ]
  • time needed returning to normal physical activity after operation [ Time Frame: one year or until reoperation ]
  • days spent on sick-leave [ Time Frame: one year or until reoperation ]
  • health care costs and total costs [ Time Frame: one year ]
  • postoperative wound infection rate [ Time Frame: one year or until reoperation ]
  • recurrence rate [ Time Frame: one year or until reoperation ]
  • 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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
125
March 2016
March 2016   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00412659
PSIN-05-178M
Not Provided
Not Provided
Not Provided
Markku Haapamaki, Umeå University
Umeå University
  • County Council of Norrbotten, 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
May 2016

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