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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00412659
Enrollment
125
Registered
2006-12-18
Start date
2006-03-31
Completion date
2016-03-31
Last updated
2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus

Keywords

Sinus, Pilonidal, Pilonidal sinus, Pilonidal cysts, Pilonidal disease, midline excision, Karydakis operation, expertise based study, surgery, therapy

Brief 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.

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.

Interventions

PROCEDURESurgery for pilonidal disease, midline excision

A midline excision is made for the treatment of pilonidal sinus disease.

PROCEDURESurgery for pilonidal disease, Karydakis operation

A Karydakis operation is done for the treatment of pilonidal sinus disease.

Sponsors

County Council of Norrbotten, Sweden
CollaboratorOTHER_GOV
Norrlandstingens Regionförbund
CollaboratorOTHER
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
time to complete wound healingone year or until reoperation

Secondary

MeasureTime frame
time needed returning to normal physical activity after operationone year or until reoperation
days spent on sick-leaveone year or until reoperation
health-related quality of lifeone year
postoperative wound infection rateone year or until reoperation
recurrence rateone year or until reoperation
health care costs and total costsone year

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026