[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578113":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure)","EXPERIMENTAL","Prophylactic defect closure will be performed using at least one new generation closure device.",[13],"Procedure: Prophylactic defect closure",{"label":15,"type":16,"description":17,"interventionNames":18},"Endoscopic Mucosal Resection (EMR)","ACTIVE_COMPARATOR","After performing EMR with thermal ablation, prophylactic defect closure will not be performed.",[19],"Procedure: No prophylactic defect closure",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Prophylactic defect closure","Endoscopists will use at least one new generation closure device to approximate the healthy mucosal surrounding the submucosal defect to ensure complete defect closure. Adequate apposition of the mucosal defect margins will be achieved when no visible submucosal areas \\>3 mm along the closure line are present.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"No prophylactic defect closure",[15],[31],{"facility":32,"status":33,"city":34,"state":35,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Centre Hospitalier de l'Université de Montréal","RECRUITING","Montreal","Quebec","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-73.58781,45.50884,{"lat":42,"lon":41},[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Samira Hanin","CONTACT","514-890-8000","30916","samira.hanin.chum@ssss.gouv.qc.ca",{"name":52,"role":47,"phone":26,"phoneExt":26,"email":26},"Daniel von Renteln, MD",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Daniel Von Renteln","Gastroenterologist, MD","100578113","complete-closure-after-endoscopic-mucosal-resection-of-large-non-pedunculated-colorectal-polyps-100578113",false,"NCT06807073","Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps","Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: a Randomized Controlled Trial","Closure-RCT","Inclusion Criteria:\n\n* adult ≥18 years old\n* patients undergoing EMR for a large (≥20mm) colorectal LSL\n* patients providing written and informed consent for study participation.\n\nExclusion Criteria:\n\n* inflammatory bowel disease;\n* non-elective colonoscopy;\n* poor general health (American Society of Anesthesiologists classification \\>III);\n* coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets \\\u003C50 x 109\u002FL);\n* pedunculated polyps (Paris class Ip, Isp);\n* overt signs of deep submucosal invasive cancer (JNET 3);\n* appendiceal orifice or terminal ileum invasion;\n* pregnancy.","ALL","18 Years",{"count":68,"type":69},686,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs.\n\nThe hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed.\n\nFor participants with planned EMR, endoscopists will perform EMRs as per standard of care and:\n\n* prophylactic defect closure will either not be performed (control group), or will be performed (experimental group);\n* then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event;\n* finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.",[75,76],"Colorectal Cancer","Polyp of Colon","2025-02-07",{"date":79,"type":80},"2025-02-11","ACTUAL",{"date":82,"type":69},"2025-02",{"date":84,"type":69},"2027-07",{"name":5,"class":6},1]