Clinical trial · Interventional
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
NCT00412659CI-TRIAL-00022446completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery for pilonidal disease, Karydakis operation | Procedure | — | UNRESOLVED |
| Surgery for pilonidal disease, midline excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Midline excision
- description
- Midline excision for pilonidal sinus disease.
- interventionNames
- Procedure: Surgery for pilonidal disease, midline excision
- type
- ACTIVE_COMPARATOR
- label
- Karydakis
- description
- Karydakis operation for pilonidal sinus disease.
- interventionNames
- Procedure: Surgery for pilonidal disease, Karydakis operation
Primary outcomes (1)
- measure
- time to complete wound healing
- timeFrame
- one year or until reoperation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDDevereaux 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. doi: 10.1136/bmj.330.7482.88. PMID 15637373
- BACKGROUNDPetersen 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. doi: 10.1007/s10350-004-6451-2. PMID 12432292
- BACKGROUNDKarydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available. PMID 4128725
- BACKGROUNDDalenback 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. doi: 10.1111/j.1463-1318.2004.00693.x. PMID 15521941
- DERIVEDHemmingsson O, Binnermark F, Odensten C, Rutegard M, Franklin KA, Haapamaki MM. Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial. BJS Open. 2022 Mar 8;6(2):zrac007. doi: 10.1093/bjsopen/zrac007. PMID 35289848