[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554013":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":26,"responsibleParty":89,"collaborators":7,"id":92,"slug":7,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":7,"enrollmentInfo":101,"targetDuration":7,"studyType":104,"phases":7,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":54,"whyStopped":7,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Routine endoscopic anastomosis inspection","The routine care pathway for early detection of anastomotic leakage includes:\n\n* C-reactive protein guided imaging\n* Rectoscopy of the anastomosis three to six days after surgery\n* Rectoscopy of the anastomosis two to three weeks after surgery",[14],{"name":15,"affiliation":16,"role":17},"Roel Hompes, MD PhD","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[19,23],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},"CONTACT","020 - 444 4400","r.hompes@amsterdamumc.nl",{"name":24,"role":20,"phone":7,"phoneExt":7,"email":25},"David Nijssen, MD","d.nijssen@amsterdamumc.nl",[27,41,53,65,77],{"facility":28,"status":29,"city":30,"state":7,"zip":7,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Bordeaux Colorectal Institute Academy","NOT_YET_RECRUITING","Bordeaux","France",{"type":33,"coordinates":34},"Point",[35,36],-0.58046,44.84124,{"lat":36,"lon":35},[39],{"name":40,"role":20,"phone":7,"phoneExt":7,"email":7},"Quentin Denost",{"facility":42,"status":29,"city":43,"state":7,"zip":7,"country":44,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Humanitas Research Hospital","Milan","Italy",{"type":33,"coordinates":46},[47,48],9.18951,45.46427,{"lat":48,"lon":47},[51],{"name":52,"role":20,"phone":7,"phoneExt":7,"email":7},"Antonino Spinelli",{"facility":16,"status":54,"city":55,"state":7,"zip":7,"country":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"RECRUITING","Amsterdam","Netherlands",{"type":33,"coordinates":58},[59,60],4.88969,52.37403,{"lat":60,"lon":59},[63],{"name":64,"role":20,"phone":7,"phoneExt":7,"email":7},"Roel Hompes",{"facility":66,"status":29,"city":67,"state":7,"zip":7,"country":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University Hospital Vall D'Hebron","Barcelona","Spain",{"type":33,"coordinates":70},[71,72],2.15899,41.38879,{"lat":72,"lon":71},[75],{"name":76,"role":20,"phone":7,"phoneExt":7,"email":7},"Eloy Espin",{"facility":78,"status":29,"city":79,"state":7,"zip":7,"country":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Imperial College London","London","United Kingdom",{"type":33,"coordinates":82},[83,84],-0.12574,51.50853,{"lat":84,"lon":83},[87],{"name":88,"role":20,"phone":7,"phoneExt":7,"email":7},"James Kinross",{"type":17,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Roel Hompes, MD","Dr. Roel Hompes, principal investigator","100554013",false,"NCT06493565","Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage","Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)","REAL","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. The participant underwent an open or minimally invasive, sphincter preserving surgery with the construction of a colorectal or coloanal anastomosis ≤15 centimetres from the anorectal junction.\n3. Adequate comprehension of the country specific or English language\n4. Written informed consent\n\nExclusion Criteria:\n\n1\\. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)","ALL","18 Years",{"count":102,"type":103},150,"ESTIMATED","OBSERVATIONAL","The objective of this international prospective observational study is to evaluate the implementation of a point-of-care digital rectoscope (LumenEye) into routine care to detect colorectal anastomotic leakage in the early postoperative period.\n\nThe study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis ≤15 centimeters from the anorectal junction. The participating centers consist of expert colorectal units in various countries.\n\nThe primary endpoint for the study is the time to diagnosis of anastomotic leakage.",[107],"Anastomotic Leak Rectum",[109,110,111,112,113],"Anastomotic leakage","Colorectal cancer","Rectoscopy","Endoscopy","Point-of-care","2024-07-01",{"date":116,"type":117},"2024-07-10","ACTUAL",{"date":119,"type":117},"2024-05-01",{"date":121,"type":103},"2026-05",{"name":5,"class":6},5]