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

NCT07156188 | Not Yet Recruiting

• 1 other identifier: H24-03475
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 5

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 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

Keywords

Umbilical hernia; Hernia repair surgery; Suture use

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Recurrence will be diagnosed clinically at the time of follow-up. Clinical diagnosis of hernia recurrence will be determined by a standard medical assessment (ie. physical exam). In the event that clinical recurrence is uncertain, a computed tomography scan or ultrasound will be performed while the patient performs a Valsalva maneuver.

  24 months

Secondary Outcomes (5)

• SSO

  30 days, 12 months, 24 months

• SSOPI

  30 days, 12 months, 24 months

• Quality of Life - HerQLes

  30 days, 12 months, 24 months

• Quality of Life - SF-12

  30 days, 12 months, 24 months

• Post-Operative Complications

  30 days

Study Arms (2)

Permenant Suture

ACTIVE COMPARATOR

Repair with permanent 0-0 polypropylene suture.

Other: Permanent Suture

Absorbable Suture

ACTIVE COMPARATOR

Repair with an 0-0 polydioxanone suture

Other: Absorbable

Interventions

Permanent Suture OTHER

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.

Also known as: Control, polypropylene

Permenant Suture

Absorbable OTHER

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.

Also known as: Polydioxanone

Absorbable Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• North York General Hospital: collaborator
• Royal Victoria Hospital Of Barrie: collaborator
• London Health Sciences Centre: collaborator
• University of Alberta: collaborator

Study Sites (5)

Royal Alexandra Hospital/University of Alberta

Edmonton, Alberta, Canada

Location

Royal Victoria Hospital

Barrie, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

North York General Hospital

North York, Ontario, Canada

Location

Vancouver Coastal Health

Vancouver, Canada

Location

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MeSH Terms

Conditions

Hernia, Umbilical

Interventions

Polypropylenes; Polydioxanone

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Polyesters; Biocompatible Materials

Central Study Contacts

Rachel Liu Hennessey

CONTACT

604-875-5790; gs@hnsy.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, University of British Columbia; General Surgeon, Vancouver General Hospital

Model Details: The PAPYRUS Trial is the first Canada-wide, multi-centre, prospective, parallel arm, non-inferiority, single blind randomized controlled trial of patients undergoing elective suture repair of small (≤2cm) primary umbilical hernia comparing non-absorbable (polypropylene) suture control group versus absorbable (polydioxanone) suture intervention group. An online web-based central method (built-in on UBC FoM REDCap) will be used for randomization. Randomization must occur intraoperatively to ensure the exclusion criteria that can only be determined during surgery are met and the surgeon confirms defect size. Participants will be followed up at 30 days, 12 months, and 2 years following surgery for assessment. The study visits will be aligned with their standard of care clinic visits.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)