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

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 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.

Conditions

• Hernia Surgery
• Umbilical Hernia Repair

Interventions

OTHER

Permanent Suture

In both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed in a standardized manner. In the control group, a permanent 0-0 polypropylene suture will be used to close the hernia defect in a transverse or vertical interrupted fashion using either the simple interrupted or the figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.

OTHER

Absorbable

In both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed. An 0-0 polydioxanone suture (PDS) will be used to close the hernia defect in either a transverse or vertical interrupted fashion using either simple interrupted or figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.

Sponsors & Collaborators

• North York General Hospital

  collaborator OTHER

• Royal Victoria Hospital Of Barrie

  collaborator UNKNOWN

• London Health Sciences Centre

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of British Columbia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2028-12-31

Completion

2030-12-31

Countries

• Canada

Study Locations