Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412659
• Other study ID #: PSIN-05-178M
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 15, 2006
• Last updated: May 31, 2016
• Start date: March 2006
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• Surgery for pilonidal disease, midline excision
A midline excision is made for the treatment of pilonidal sinus disease.
• Surgery for pilonidal disease, Karydakis operation
A Karydakis operation is done for the treatment of pilonidal sinus disease.

Locations

Country	Name	City	State
Sweden	Sunderby Regional Hospital	Luleå
Sweden	Umeå University Hospital	Umeå

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	County Council of Norrbotten, Sweden, Norrlandstingens Regionförbund

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Dalenbäck J, Magnusson O, Wedel N, Rimbäck 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. — View Citation

Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. Review. — View Citation

Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to complete wound healing		one year or until reoperation	No
Secondary	health-related quality of life		one year	No
Secondary	time needed returning to normal physical activity after operation		one year or until reoperation	No
Secondary	days spent on sick-leave		one year or until reoperation	No
Secondary	health care costs and total costs		one year	No
Secondary	postoperative wound infection rate		one year or until reoperation	No
Secondary	recurrence rate		one year or until reoperation	No