Status:
NOT_YET_RECRUITING
The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
North York General Hospital
Royal Victoria Hospital Of Barrie
Conditions:
Hernia Surgery
Umbilical Hernia Repair
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Umbilical hernias can be found in over a quarter of the population and comprise of 15% of hernia repairs performed in Canada. While mesh repair is commonly used for larger hernias, smaller hernia defe...
Detailed Description
Umbilical hernias make up a notable proportion of abdominal wall hernia repairs annually. Up to 25% of the population have asymptomatic umbilical hernias when examined using ultrasound. Recent compute...
Eligibility Criteria
Inclusion
- Elective surgery for primary umbilical hernia with a defect ≤ 2 cm measured clinically or radiographically
- Age 19 years or older
- Patient able to give oral and written informed consent
Exclusion
- Umbilical hernia defect \> 2 cm measured clinically, radiologically, or intraoperatively with ruler
- Multiple defects
- Incisional hernia: prior hernia in area of operation
- Recurrent umbilical hernia
- Epigastric hernia
- Secondary operation performed simultaneously
- Pregnancy
- Infected wounds
- Acute operation (incarcerated or strangulated hernia)
- BMI ≥ 35 kg/m\^2
- Ascites or liver cirrhosis
- Peritoneal dialysis
- Immunosuppression
- Connective tissue disorder
- Patient deemed unfit for primary repair at time of surgery based on surgeon discretion at time of operation (e.g. poor tissue quality or unexpected operative finding)
- Defect is made in the umbilical skin or skin incision extended beyond paraumbilical incision (e.g. sigma or midline extended incision)
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
914 Patients enrolled
Trial Details
Trial ID
NCT07156188
Start Date
January 1 2026
End Date
December 31 2030
Last Update
September 30 2025
Active Locations (5)
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1
Royal Alexandra Hospital/University of Alberta
Edmonton, Alberta, Canada
2
Royal Victoria Hospital
Barrie, Ontario, Canada
3
London Health Sciences Centre
London, Ontario, Canada
4
North York General Hospital
North York, Ontario, Canada