Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus
Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedSeptember 5, 2017
September 1, 2017
5.2 years
August 17, 2017
September 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete healing
percentage of complete healing
3 weeks
Secondary Outcomes (2)
Time to recovery
12 months
percentage of relapse
12 months
Study Arms (2)
Primary closure
EXPERIMENTALExcision of sinus and paramedian closure according to modified Karydakis technique
Fistulectomy
EXPERIMENTALRemoval / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention
Interventions
Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
Eligibility Criteria
You may qualify if:
- Pilonidal cyst requiring surgery
- Signed Informed Consent Form
You may not qualify if:
- Abnormal lesions
- Injuries requiring a closing with rotation flap
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Regionale di Lugano
Lugnao, 6900, Switzerland
Related Publications (1)
Popeskou 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: 32144531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice-Chief in Surgery
Study Record Dates
First Submitted
August 17, 2017
First Posted
September 5, 2017
Study Start
April 1, 2012
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
September 5, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share