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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00412659
Other study ID # PSIN-05-178M
Secondary ID
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


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
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