A Trial in Mini-invasive Pilonidal Sinus Disease Surgery
Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
1 other identifier
interventional
188
1 country
1
Brief Summary
Pilonidal sinus disease is a chronic acquired disease leading to significant morbidity and healthcare costs in young man and women. Despite different treatment methods, the disease relatively often leads to postoperative complications and recurrence.(8). Advantages of mini-invasive techniques include: quicker recovery and earlier return to work and high patient satisfaction. Randomized studies are rare and this applies especially to newer mini-invasive techniques. The purpose of the investigators prospective study is to randomly compare the mini-invasive laser ablation technique to the mini-invasive fibrin glue treatment in pilonidal sinus disease surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
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
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 17, 2029
May 9, 2025
April 1, 2025
5.8 years
April 23, 2025
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Healing rate
Healing rate will be assessed by a questionnaire and a phone call
2 months after surgery
Quality of life
Quality of life will be assessed by a questionnaire, the RAND 36-Item Health Survey
2 months after surgery
Secondary Outcomes (5)
Recurrence rate
1, 3 and 5 years after surgery
Cost analysis
At 2 months after surgery
Postoperative complications
2 - 3 months after the surgery
Sick leave
2 months and 1 year after surgery
Recovery time
2 months and 1 year after surgery
Study Arms (2)
study group 1
ACTIVE COMPARATORsurgery + laser ablation
study group 2
ACTIVE COMPARATORsurgery + fibrine glue
Interventions
Eligibility Criteria
You may qualify if:
- primary pilonidal sinus disease
- age 18 and above
You may not qualify if:
- recurrent pilonidal sinus disease
- age under 18
- inability to understand Finnish or Swedish (the questionnaires are in Finnish and Swedish only, the two official languages of Finland)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HUS Vatsakeskus Abdominal Center of Helsinki University Hospital
Helsinki, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pauli Puolakkainen, Professor
University of Helsinki, Department of Surgery
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
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2025
First Posted
May 9, 2025
Study Start
September 1, 2023
Primary Completion (Estimated)
June 17, 2029
Study Completion (Estimated)
December 17, 2029
Last Updated
May 9, 2025
Record last verified: 2025-04