An interventional study of Permanent Suture and Absorbable in Hernia Surgery and Umbilical Hernia Repair, sponsored by University of British Columbia. Not yet recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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 computed tomography studies have identified umbilical hernia in up to 62% of the population. In Canada in 2019, there were 66,234 hernia surgeries performed. Similarly, there are around 175,000 umbilical hernia repairs per year in the United States.
The European Hernia Society (EHS) guidelines classify umbilical hernias by size as small (0-1cm), medium (more than 1 cm up to 4cm), and large (over 4 cm) based on diameter. Although many hernias are asymptomatic, intra-abdominal contents, such as fat or bowel, can protrude through the defect and result in a surgical emergency. Up to 20% of patients with asymptomatic umbilical hernia will later require elective surgery, and another 4% will require emergency surgery.
The EHS guidelines recommend mesh for all hernia repairs to reduce rate of recurrence, but quality of evidence is limited for hernias less than 1cm in size and therefore suture repair can be considered in these situations. Despite EHS guidelines, in many cases, umbilical hernias up to 2 cm in size are repaired with suture based on intra-operative assessment, for example, to avoid enlarging the defect necessary to accommodate a pre-peritoneal mesh with an overlap of 3cm.
The Americas Hernia Society Quality Collaborative Database found that mesh repairs were used for 82% of umbilical hernias >1cm in diameter and 33% of those ≤1cm in diameter. For the National Health Service in England, 50% of umbilical hernias were repaired with mesh. This has led to the controversial reclassification of small hernias to those \<2cm in size. Of small (\<2cm) umbilical hernias captured by Herniamed, a hernia registry in Germany, Austria, and Switzerland, suture repair was performed for 76.5% of all cases.
The double-blind multicentre randomized controlled trial by Kauffmann and colleagues. compared suture to mesh repair of primary umbilical hernias and found an 8% recurrence rate following suture repair of umbilical hernias 1-2cm in size.
Based on clinical experience, there does appear to be higher rates of granuloma formation, sinus tract formation, and wound complications following the use of non-absorbable sutures. A systematic review and meta-analysis of techniques for the closure of midline abdominal incisions compared absorbable and non-absorbable suture and identified increased pain and suture sinus formation with the use of non-absorbable suture. Another systematic review comparing slowly absorbable versus non-absorbable suture for laparotomy fascial closure found no difference in hernia rate, but a higher rate of suture sinus formation after using non-absorbable suture. Rat models have also demonstrated that slowly absorbable polydioxanone suture may be preferable to permanent polypropylene suture due to a favourable macrophage response. Two large Danish studies compared non-absorbable, slowly absorbable, and quickly absorbable sutures and found no significant difference in recurrence rates.
There is currently insufficient evidence to recommend a suture type or technique for the suture repair of small umbilical hernias. The PAPYRUS Trial will help guide surgical management and suture decisions for thousands of patients annually in North America.
Common umbilical hernia repair complications include wound infection, pain, or hematoma. Multiple terms exist to describe complications following hernia surgery, and the Ventral Hernia Working Group has endeavoured to standardize this nomenclature by defining surgical site occurrence (SSO) and surgical site occurrences requiring procedural intervention (SSOPI). The PAPYRUS Trial will utilize these metrics as outcome variables because SSO will capture suture complications.
Suture type may play a role in reducing risk of recurrence and post-operative complications following primary suture repair of umbilical hernia. There have been no recent systematic reviews or meta-analyses comparing suture types for umbilical hernia. In the systematic review comparing mesh versus suture for elective repair of umbilical hernia, the studies using slowly absorbable suture may favour suture repair, whereas those using permanent suture may favour mesh repair. The European Hernia Society Guidelines state that there is insufficient clinical literature to determine whether permanent or absorbable suture should be used for the primary open repair of small umbilical hernias. This trial is needed to guide the best practices on the use of suture type when performing suture repair of primary umbilical hernia.
The results of this trial will add to the limited evidence base of the surgical management of umbilical hernias ≤2 cm in size and inform treatment guidelines for suture selection in the management of suture repair for primary umbilical hernia. This trial will guide surgical decisions on preferred suture material for primary umbilical hernia repair based on differences or lack of differences in recurrence, SSO, SSOPI, and patient-reported QoL.
Thus, the research question for this trial is: Does slowly absorbable polydioxanone suture compared to permanent polypropylene suture for primary open repair of small \<2 cm umbilical hernias result in non-inferior recurrence, SSO, SSOPI, or QoL at 24 months following surgery?
The primary hypothesis is that slowly absorbable polydioxanone suture will be non-inferior (at a non-inferiority margin of 5%) to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias for recurrence at 24 months.
Secondary hypotheses are:
Slowly absorbable polydioxanone suture is non-inferior to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias in patient-reported QoL as measured by the HerQLes and the SF-12 surveys at 24 months.
All analyses will be conducted on the intention-to-treat (ITT) population. Continuous data will be expressed as means and standard deviations and analyzed using two-sample t-test. Categorical data will be expressed as contingency tables using counts and percentages and analyzed using Chi-squared test or Fisher's exact test.
Recurrence, SSO, and SSOPI will be analyzed as follows:
HerQLes and SF-12 scores:
Subgroup analyses will be conducted to evaluate differences in hernia risk factors and sites. All analyses will be conducted using R Statistical Software (v4.5.0; Vienna, Austria).
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's planned enrollment of 914 is above the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repair with permanent 0-0 polypropylene suture.
Other: Permanent Suture
Repair with an 0-0 polydioxanone suture
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 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
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
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.
Time frame: 24 months
SSO
SSO will be diagnosed according to the Ventral Hernia Working Group definition which includes: surgical site infection, seroma, dehiscence, enterocutaneous fistula, surgical site infection, seroma, wound dehiscence, enterocutaneous fistula, wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma, and infected or exposed mesh.
Time frame: 30 days, 12 months, 24 months
SSOPI
Surgical Site Occurrences (SSOs) requiring a procedural intervention, defined as wound opening or debridement, suture excision, or percutaneous drainage
Time frame: 30 days, 12 months, 24 months
Quality of Life - HerQLes
The Hernia-Related Quality of Life Survey (HerQLes) is a validated patient-reported outcome measure specific to abdominal wall hernias, verified in a subgroup analysis of patients with small hernias. The HerQLes includes 12 statements related to the abdominal wall. Each of the 12 statements is scored from 1 to 6 (strongly disagree to strongly agree, respectively). Each statement covers a domain relevant to hernia-related QoL, and the scores can be compared for each statement and in aggregate. Summary scores are calculated using the following formula: (120-\[(20/12)∗(raw score)\]).
Time frame: 30 days, 12 months, 24 months
Quality of Life - SF-12
The 12-item Short Form Survey from the RAND Medical Outcomes Study (SF-12) is a general health status questionnaire, a truncated and validated version of the extensively used 36-item Short Form Survey (SF-36), used to assess baseline health and postoperative recovery. The SF-12 is a self-reported health-related QoL questionnaire comprised of 12 items, including 8 domains of health (physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health). In accordance with prior hernia research, the results of test items will be normalized and expressed in terms of 2 meta-scores: Physical Component Summary and Mental Component Summary. A higher SF-12 score is indicative of better functioning.
Time frame: 30 days, 12 months, 24 months
Post-Operative Complications
Complications will be determined at follow-up 30 days after surgery and will be defined based on Clavien-Dindo criteria (Clavien et al., 2009).
Time frame: 30 days
Plan to share: No — Patients will be assigned a unique study ID and no identifiers will be retained for analysis. A master list linking patients' PHN and the study ID will be retained only during data collection to avoid duplication of data entry. The master list will be stored as a password protected Excel spreadsheet on the institutional share drive. Only study personnel will have access to the spreadsheet. Once the collection is completed, this master list will be deleted and data will be completely de-identified. All de-identified data are recorded and stored on each institution's REDCap. Only the Lead Site research team will have the ability to see the entire dataset when processing and analyzing; each collaborating site will only be able to see data they input from their own site. This is to protect patient data, in accordance with provincial health information policies.
Start is estimated for Jan 2026; primary completion for Dec 2028, 35 months later.
Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of British Columbia →