[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487503":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":37,"collaborators":39,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":7,"enrollmentInfo":55,"targetDuration":58,"studyType":59,"phases":7,"briefSummary":60,"conditions":61,"keywords":7,"overallStatus":63,"whyStopped":7,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Odense University Hospital","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","qICG","Evaluation of bowel fluorescence by pixel software, qICG",[14],{"name":15,"affiliation":16,"role":17},"Mark Ellebaek, MD, PhD","Consultant Surgeon","PRINCIPAL_INVESTIGATOR",[19],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Pernille Larsen, MD","CONTACT","+4579405604","pernille.oehlenschlager.larsen0@rsyd.dk",[25],{"facility":5,"status":7,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":7},"Odense","Fyn","5000","Denmark","DK",{"type":32,"coordinates":33},"Point",[34,35],10.38831,55.39594,{"lat":35,"lon":34},{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[40,42],{"name":41,"class":6},"Rigshospitalet, Denmark",{"name":43,"class":6},"Vejle Hospital","100487503","quantification-of-anastomostic-blood-flow-with-fluorescence-imaging-in-low-anterior-resection-for-rectal-cancer-100487503",false,"NCT05627934","Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer","Quantification of Anastomotic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer, FILAR. -Can we Identify Cut-off Values to Diminish the Risk of Anastomotic Leakage. A Prospective Multicentre Study","FILAR","Inclusion Criteria:\n\n* Patients, older than 18, undergoing laparoscopic or robotic surgery for rectal cancer, with or without combination with trans-anal approach.\n\nExclusion Criteria:\n\n* Allergy of iodide. Terminal renal disease. Pregnancy. Lactation. Previous left side colon resection or major surgery on intraabdominal vessels.",true,"ALL","18 Years",{"count":56,"type":57},168,"ESTIMATED","1 Year","OBSERVATIONAL","A serious and life-threatening complication to rectal surgery is anastomotic leakage, AL. In Denmark, approximately 800 patients every year, are operated for rectal cancer, 50% of these with resection and anastomosis.\n\nThe registered leakage rate for rectal anastomosis is 10-15%. AL can be life threatening and has long-term adverse effects for the patients, with reduced quality of life, due to a poor functional result of the neo-rectum known as low anterior rectal syndrome (LARS). Fistulas to the vagina or urinary tract are other severe complications. Furthermore, AL is associated with an increased risk of reccurence1. Finally, the AL-associated morbidity is also a significant economic burden to the health care system due to prolonged hospital stay, medicine, and reoperations.\n\nDuring surgery it is important to ensure optimal healing conditions for the anastomosis. The blood flow is evaluated by colour and pulsation in the mesentery.\n\nStudies suggest that it might be easier to evaluate the perfusion using fluorescent dye. This evaluation is a subjective evaluation, based mostly on the surgeon's experience.\n\nAssessing fluorescence by computer-based software, qICG, has been developed. But cut-off values for sufficient blood flow to diminish the risk of leakage, has not yet been defined.\n\nAim:\n\nPrimary objective: To establish cut-off values of qICG, where blood flow assumes sufficient for healing, and thereby reduce the risk of leakage.\n\nSecondary objective: To identify which long-term complications grade A, B and C leakages entails on Quality of Life.",[62],"Anastomotic Leak","NOT_YET_RECRUITING","2022-11-17",{"date":66,"type":67},"2022-11-28","ACTUAL",{"date":69,"type":57},"2023-03-01",{"date":71,"type":57},"2027-03-01",{"name":5,"class":6},1]