Mid-Line Excision Versus Karydakis Operation for Pilonidal Sinus - Full Text View

Sponsors and Collaborators:	Umeå University County Council of Norrbotten, Sweden County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND)
Information provided by:	Umeå University
ClinicalTrials.gov Identifier:	NCT00412659

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 II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
postoperative wound infection rate
recurrence rate

Secondary Outcome Measures:

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

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
Midline excision: Active Comparator 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.
Karydakis: Active Comparator 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 we 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

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
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
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

Sponsors and Collaborators

Umeå University

County Council of Norrbotten, Sweden

County Councils of Northern 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:

Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. Review. No abstract available.

Petersen S, Koch R, Stelzner S, Wendlandt TP, Ludwig K. Primary closure techniques in chronic pilonidal sinus: a survey of the results of different surgical approaches. Dis Colon Rectum. 2002 Nov;45(11):1458-67.

Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. No abstract available.

Dalenback J, Magnusson O, Wedel N, Rimback G. Prospective follow-up after ambulatory plain midline excision of pilonidal sinus and primary suture under local anaesthesia--efficient, sufficient, and persistent. Colorectal Dis. 2004 Nov;6(6):488-93.

Responsible Party:	Umea University, Department of Surgery ( Markku Haapamaki MD, PhD )
Study ID Numbers:	PSIN-05-178M
Study First Received:	December 15, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00412659
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

Study placed in the following topic categories:

Pilonidal Sinus
Cysts

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009