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
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
  Purpose

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.


Condition Intervention Phase
Pilonidal Sinus
Procedure: Surgery for pilonidal disease, midline excision
Procedure: Surgery for pilonidal disease, Karydakis operation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • time to complete wound healing [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 360
Study Start Date: March 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Midline excision
Midline excision for pilonidal sinus disease.
Procedure: Surgery for pilonidal disease, midline excision
A midline excision is made for the treatment of pilonidal sinus disease.
Active Comparator: Karydakis
Karydakis operation for pilonidal sinus disease.
Procedure: Surgery for pilonidal disease, Karydakis operation
A Karydakis operation is done for the treatment of pilonidal sinus disease.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412659

Contacts
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

Locations
Sweden
Sunderby Regional Hospital Recruiting
Luleå, Sweden, SE 972 80
Contact: Christoffer Odensten, MD    +46 920 28000    christoffer.odensten@nll.se   
Contact: Lars Andersson, MD    +46 920 28000    lars.andersson@nll.se   
Principal Investigator: Christoffer Odensten, MD         
Umeå University Hospital Recruiting
Umeå, Sweden, SE 90185
Contact: Markku M Haapamaki, MD, PhD    +46-907852013    markku.haapamaki@surgery.umu.se   
Contact: Owe Lundberg, MD, PhD    +46-907850000    owe.lundberg@vll.se   
Principal Investigator: Markku M Haapamaki, MD, PhD         
Sponsors and Collaborators
Umeå University
County Council of Norrbotten, Sweden
Norrlandstingens Regionförbund
Investigators
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
  More Information

Publications:
Responsible Party: Markku Haapamaki, Associate professor, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT00412659     History of Changes
Other Study ID Numbers: PSIN-05-178M
Study First Received: December 15, 2006
Last Updated: October 26, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
Sinus, Pilonidal
Pilonidal sinus
Pilonidal cysts
Pilonidal disease
midline excision
Karydakis operation
expertise based study
surgery
therapy

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014