The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia

About this trial

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 defects are often closed with sutures alone. While non-absorbable sutures may have greater tensile strength, the use of absorbable sutures has been found to reduce the risk for wound infection and improve healing. The objective of this multi-centre, nationwide randomized controlled study is to determine whether there is a difference in hernia recurrence when the repair is completed with absorbable polydioxanone suture versus permanent polypropylene suture. The study will also explore post-operative complications and quality of life. Recruitment will take place over 5 years with follow-up at the 30-day, 12-month and 24-month mark following surgery. The results of this trial will be directly applicable to national and international hernia guidelines and will impact the care of thousands of patients.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Permanent Suture
  • Absorbable

Treatment groups

914 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of British Columbia

Lead sponsor

North York General Hospital

Collaborator

Royal Victoria Hospital Of Barrie

Collaborator

London Health Sciences Centre

Collaborator

University of Alberta

Collaborator