[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554013":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":26,"responsibleParty":94,"collaborators":7,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":7,"enrollmentInfo":107,"targetDuration":7,"studyType":110,"phases":7,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":56,"whyStopped":7,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"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",[27,42,55,68,81],{"facility":28,"status":29,"city":30,"state":7,"zip":7,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Bordeaux Colorectal Institute Academy","NOT_YET_RECRUITING","Bordeaux","France","FR",{"type":34,"coordinates":35},"Point",[36,37],-0.58046,44.84124,{"lat":37,"lon":36},[40],{"name":41,"role":20,"phone":7,"phoneExt":7,"email":7},"Quentin Denost",{"facility":43,"status":29,"city":44,"state":7,"zip":7,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Humanitas Research Hospital","Milan","Italy","IT",{"type":34,"coordinates":48},[49,50],9.18951,45.46427,{"lat":50,"lon":49},[53],{"name":54,"role":20,"phone":7,"phoneExt":7,"email":7},"Antonino Spinelli",{"facility":16,"status":56,"city":57,"state":7,"zip":7,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"RECRUITING","Amsterdam","Netherlands","NL",{"type":34,"coordinates":61},[62,63],4.88969,52.37403,{"lat":63,"lon":62},[66],{"name":67,"role":20,"phone":7,"phoneExt":7,"email":7},"Roel Hompes",{"facility":69,"status":29,"city":70,"state":7,"zip":7,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University Hospital Vall D'Hebron","Barcelona","Spain","ES",{"type":34,"coordinates":74},[75,76],2.15899,41.38879,{"lat":76,"lon":75},[79],{"name":80,"role":20,"phone":7,"phoneExt":7,"email":7},"Eloy Espin",{"facility":82,"status":29,"city":83,"state":7,"zip":7,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Imperial College London","London","United Kingdom","UK",{"type":34,"coordinates":87},[88,89],-0.12574,51.50853,{"lat":89,"lon":88},[92],{"name":93,"role":20,"phone":7,"phoneExt":7,"email":7},"James Kinross",{"type":17,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Roel Hompes, MD","Dr. Roel Hompes, principal investigator","100554013","routine-endoscopic-evaluation-of-colorectal-anastomoses-for-early-detection-of-anastomotic-leakage-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":108,"type":109},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.",[113],"Anastomotic Leak Rectum",[115,116,117,118,119],"Anastomotic leakage","Colorectal cancer","Rectoscopy","Endoscopy","Point-of-care","2024-07-01",{"date":122,"type":123},"2024-07-10","ACTUAL",{"date":125,"type":123},"2024-05-01",{"date":127,"type":109},"2026-05",{"name":5,"class":6},5]