Clinical trial · Interventional
Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus
Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
NCT03271996CI-TRIAL-00029411terminatedN/AClinicalTrials.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)
This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.
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 |
|---|---|---|---|
| Fistulectomy | Procedure | — | UNRESOLVED |
| Primary closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Primary closure
- description
- Excision of sinus and paramedian closure according to modified Karydakis technique
- interventionNames
- Procedure: Primary closure
- type
- EXPERIMENTAL
- label
- Fistulectomy
- description
- Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention
- interventionNames
- Procedure: Fistulectomy
Primary outcomes (1)
- measure
- Complete healing
- timeFrame
- 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Pilonidal cyst requiring surgery * Signed Informed Consent Form Exclusion Criteria: * Abnormal lesions * Injuries requiring a closing with rotation flap
References
Publications (1)
- DERIVEDPopeskou SG, Pravini B, Panteleimonitis S, Vajana AFDT, Vanoni A, Schmalzbauer M, Posabella A, Christoforidis D. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6. PMID 32144531