[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":108,"collaborators":110,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":33,"enrollmentInfo":127,"targetDuration":33,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":141,"whyStopped":33,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Permenant Suture","ACTIVE_COMPARATOR","Repair with permanent 0-0 polypropylene suture.",[13],"Other: Permanent Suture",{"label":15,"type":10,"description":16,"interventionNames":17},"Absorbable Suture","Repair with an 0-0 polydioxanone suture",[18],"Other: Absorbable",[20,27],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[9],[25,26],"Control","polypropylene",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[15],[32],"Polydioxanone",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Rachel Liu Hennessey","CONTACT","604-875-5790","gs@hnsy.ca",[41,58,74,88,97],{"facility":42,"status":33,"city":43,"state":44,"zip":33,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Royal Alexandra Hospital\u002FUniversity of Alberta","Edmonton","Alberta","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-113.46871,53.55014,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":33,"email":57},"Ram Anantha, MD, FRCSC","(780) 613-5790","ranantha@ualberta.ca",{"facility":59,"status":33,"city":60,"state":61,"zip":33,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Royal Victoria Hospital","Barrie","Ontario",{"type":48,"coordinates":63},[64,65],-79.66634,44.40011,{"lat":65,"lon":64},[68,72],{"name":69,"role":37,"phone":70,"phoneExt":33,"email":71},"George Pang","(249) 388-3712","george.pang2001@gmail.com",{"name":69,"role":73,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"facility":75,"status":33,"city":76,"state":61,"zip":33,"country":45,"countryCode":46,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"London Health Sciences Centre","London",{"type":48,"coordinates":78},[79,80],-81.23304,42.98339,{"lat":80,"lon":79},[83,87],{"name":84,"role":37,"phone":85,"phoneExt":33,"email":86},"Eric Walser","5196633269","Ericwwalser@gmail.com",{"name":84,"role":73,"phone":33,"phoneExt":33,"email":33},{"facility":89,"status":33,"city":90,"state":61,"zip":33,"country":45,"countryCode":46,"cosmosGeoPoint":33,"geoPoint":33,"contacts":91},"North York General Hospital","North York",[92,96],{"name":93,"role":37,"phone":94,"phoneExt":33,"email":95},"Benjamin Fung","416-827-6327","benjamin.a.fung@gmail.com",{"name":93,"role":73,"phone":33,"phoneExt":33,"email":33},{"facility":98,"status":33,"city":99,"state":33,"zip":33,"country":45,"countryCode":46,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Vancouver Coastal Health","Vancouver",{"type":48,"coordinates":101},[102,103],-123.11934,49.24966,{"lat":103,"lon":102},[106,107],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},{"name":36,"role":73,"phone":33,"phoneExt":33,"email":33},{"type":73,"investigatorFullName":36,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Clinical Assistant Professor, University of British Columbia; General Surgeon, Vancouver General Hospital",[111,112,115,116],{"name":89,"class":6},{"name":113,"class":114},"Royal Victoria Hospital Of Barrie","UNKNOWN",{"name":75,"class":6},{"name":117,"class":6},"University of Alberta","100604951","the-papyrus-study-permanent-vs-absorbable-sutures-in-primary-repair-of-umbilical-hernias-a-multicentre-single-blind-non-inferiority-randomized-controlled-trial-100604951",false,"NCT07156188","The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial","PAPYRUS","Inclusion Criteria:\n\n1. Elective surgery for primary umbilical hernia with a defect ≤ 2 cm measured clinically or radiographically\n2. Age 19 years or older\n3. Patient able to give oral and written informed consent\n\nExclusion Criteria:\n\n1. Umbilical hernia defect \\> 2 cm measured clinically, radiologically, or intraoperatively with ruler\n2. Multiple defects\n3. Incisional hernia: prior hernia in area of operation\n4. Recurrent umbilical hernia\n5. Epigastric hernia\n6. Secondary operation performed simultaneously\n7. Pregnancy\n8. Infected wounds\n9. Acute operation (incarcerated or strangulated hernia)\n10. BMI ≥ 35 kg\u002Fm\\^2\n11. Ascites or liver cirrhosis\n12. Peritoneal dialysis\n13. Immunosuppression\n14. Connective tissue disorder\n15. 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)\n16. Defect is made in the umbilical skin or skin incision extended beyond paraumbilical incision (e.g. sigma or midline extended incision)","ALL","18 Years",{"count":128,"type":129},914,"ESTIMATED","INTERVENTIONAL",[132],"NA","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.",[135,136],"Hernia Surgery","Umbilical Hernia Repair",[138,139,140],"Umbilical hernia","Hernia repair surgery","Suture use","NOT_YET_RECRUITING","2025-09-27",{"date":144,"type":145},"2025-09-30","ACTUAL",{"date":147,"type":129},"2026-01-01",{"date":149,"type":129},"2030-12-31",{"name":5,"class":6},5]