Pilonidal Sinus Disease
LASER ABLATION VERSUS KARYDAKIS TECHNIQUE IN THE TREATMENT OF PILONIDAL SINUS DISEASE: A COMPARATIVE STUDY
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
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
June 10, 2024
CompletedFirst Submitted
Initial submission to the registry
July 12, 2024
CompletedFirst Posted
Study publicly available on registry
July 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJuly 18, 2024
July 1, 2024
12 months
July 12, 2024
July 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence rate in the treatment of pilonidal disease
the patients undergo follow up at the outpatient clinic for manifestations of recurrence eg. discharge, multiple pits
6 months after the operation
Study Arms (2)
group (A) LASER ABLATION
ACTIVE COMPARATORgroup (B) KARYDAKIS TECHNIQUE
ACTIVE COMPARATORInterventions
group (A) will include patients with pilonidal sinus disease who will be operated by sinus tract ablation procedure using 1470 nm Diode laser
group (B) will include patients with pilonidal sinus disease who will be operated by Karydakis technique
Eligibility Criteria
You may qualify if:
- All patients with a clinical diagnosis of symptomatic uncomplicated pilonidal sinus, males or females, any age will be included in our study.
You may not qualify if:
- Patients with pilonidal abscess and any associated acute condition.
- Patients with hidradenitis suppurativa.
- Refusal.
- Unfit for surgery.
- Recurrence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University Hospital
Sohag, Egypt
Related Publications (3)
Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.
PMID: 27084534BACKGROUNDDoll D, Matevossian E, Wietelmann K, Evers T, Kriner M, Petersen S. Family history of pilonidal sinus predisposes to earlier onset of disease and a 50% long-term recurrence rate. Dis Colon Rectum. 2009 Sep;52(9):1610-5. doi: 10.1007/DCR.0b013e3181a87607.
PMID: 19690490BACKGROUNDDessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.
PMID: 28056720BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident, Department of General Surgery, Faculty of Medicine, Sohag University
Study Record Dates
First Submitted
July 12, 2024
First Posted
July 18, 2024
Study Start
June 10, 2024
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
July 18, 2024
Record last verified: 2024-07