Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus
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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 |
- time to complete wound healing [ Time Frame: one year or until reoperation ] [ Designated as safety issue: No ]
- 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 |
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| 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 |
| 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 | |
| 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 May 19, 2013