[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519150":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":11,"locations":21,"responsibleParty":47,"collaborators":7,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":7,"enrollmentInfo":59,"targetDuration":7,"studyType":62,"phases":7,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":23,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Shouldice Hospital","OTHER",null,[9],{"type":6,"name":10,"description":10,"armGroupLabels":7,"otherNames":7},"No intervention",[12,17],{"name":13,"role":14,"phone":15,"phoneExt":7,"email":16},"Christoph Paasch, MD","CONTACT","6476542790","cpaasch@shouldice.com",{"name":18,"role":14,"phone":19,"phoneExt":7,"email":20},"Marguerite Mainprize, MSc","4169316244","mmainprize@shouldice.com",[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Thornhill","Ontario","L3T 4A3,","Canada","CA",{"type":30,"coordinates":31},"Point",[32,33],-79.4163,43.80011,{"lat":33,"lon":32},[36,38,41,44,45],{"name":18,"role":14,"phone":37,"phoneExt":7,"email":20},"905-889-1125 ext. 1297",{"name":39,"role":14,"phone":37,"phoneExt":7,"email":40},"Fernando Netto Spencer, PhD","fspencernetto@shouldice.com",{"name":42,"role":43,"phone":7,"phoneExt":7,"email":7},"Christoph Paasch, PD Dr.","SUB_INVESTIGATOR",{"name":18,"role":43,"phone":7,"phoneExt":7,"email":7},{"name":39,"role":46,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100519150","patient-reported-outcomes-for-patients-undergoing-surgery-at-shouldice-hospital-100519150",false,"NCT06039800","Patient-reported Outcomes for Patients Undergoing Surgery at Shouldice Hospital.","Patient Reported Outcome Measures (PROMS): Follow up of Shouldice Hospital Patients","PROM project","Inclusion Criteria:\n\n* All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.\n\nExclusion Criteria:\n\n* Lack of an email address.","ALL","16 Years",{"count":60,"type":61},2000,"ESTIMATED","OBSERVATIONAL","Background:\n\nPrevious publications have highlighted limited data on patient outcomes and experiences at Shouldice Hospital. Existing studies from Europe reported outcomes following Shouldice repair but lacked recent data. The current project seeks to optimize patient care and knowledge through systematic follow-up.\n\nStudy Objectives:\n\nEstablish a patient-reported outcome measure follow-up program. Evaluate postoperative complication rates. Determine important outcomes to patients. Establish and monitor patient satisfaction with decision-making and hernia repair.\n\nHypotheses\u002FResearch Questions:\n\nSeveral research questions related to patient motivations, outcomes, knowledge, and satisfaction are posed for investigation.\n\nPotential Risks and Benefits:\n\nNo anticipated risks to participants. Participants won't directly benefit but contribute to improving patient care and knowledge.\n\nStudy Design:\n\nThe study employs a prospective follow-up approach. Surveys are sent at specific intervals (30-40 days, 1-year, 3-years, and 5-years) via email.\n\nConsent forms are included in the email, allowing participants to choose their level of involvement. Data is collected from survey responses, patient charts, and operative notes.\n\nStudy Population:\n\nAll patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.\n\nExclusion criteria:\n\nLack of an email address. The required sample size is unknown, and this study serves as a pilot.\n\nData Collection:\n\nData is collected from surveys, patient charts, and operative notes. Consent is obtained through deferred consent (initial contact via email, with consent forms provided).\n\nSafeguards are in place to protect personal health information.\n\nDuration of Study:\n\nEstimated to take 5-6 years. Recruitment\u002Fenrollment: 6-12 months. Follow-up: 5 years from the last enrolled participant. Data analysis and write-up: 5 months.\n\nOverlap with Other Projects:\n\nConcerns about overlap with other studies are addressed, and concurrent participation is allowed. Participants can withdraw at any time.\n\nIn summary, this research project aims to gather comprehensive data on hernia surgery outcomes, patient experiences, and satisfaction at Shouldice Hospital through a systematic follow-up approach, contributing to the improvement of patient care and knowledge in this field.",[65],"Hernia",[67,68],"hernia","groin hernia","2023-09-08",{"date":71,"type":72},"2023-09-15","ACTUAL",{"date":74,"type":72},"2023-08-01",{"date":76,"type":61},"2028-08",{"name":5,"class":6},1]