[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369214":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transanal irrigation","EXPERIMENTAL","Participants receiving TAI will irrigate once\u002Fday with stepwise volumes; 1. month 150 ml, 2. month 300 ml, and 3. month 500 ml.",[13],"Device: Qufora Irrisedo Cone System",{"label":15,"type":16,"description":17,"interventionNames":18},"Glycerol suppositories","ACTIVE_COMPARATOR","Participants treated with glycerol suppositories will administer one glycerol suppository once\u002Fday.",[19],"Drug: Glycerol \"OBA\"",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Qufora Irrisedo Cone System","The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Glycerol \"OBA\"","Rectal suppository. Stimulates the rectum and softens and loosens stool.",[15],[33],{"name":34,"affiliation":35,"role":36},"Peter Christensen","Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Mira Mekhael, M.D.","CONTACT","+4526213506","mirmek@rm.dk",{"name":44,"role":40,"phone":26,"phoneExt":26,"email":45},"Peter Christensen, Professor","petchris@rm.dk",[47],{"facility":48,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Aarhus University Hospital, Department of Surgery","RECRUITING","Aarhus","8200","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],10.21076,56.15674,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":26,"email":42},"Mira Mekhael, MD","26213506",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100369214","phase-3-comparison-of-transanal-irrigation-and-glycerol-suppositories-in-treatment-of-low-anterior-resection-syndrome-100369214",false,"NCT04087421","Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome","Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial","Inclusion Criteria:\n\n* Patients electively treated for rectal cancer with a low anterior resection.\n* Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score \\>29 at evaluation).\n* At least 3 months after surgery (including reversal of a temporary loop-ileostomy).\n* Age \\>= 18 years\n* Ability to understand written and spoken language actual for the including site (due to questionnaire validity).\n\nExclusion Criteria:\n\n* Former use of TAI\n* Prior systematic use of rectal emptying aids\n* Anastomotic stenosis\n* History of anastomotic leakage\n* Current metastatic disease or local recurrence\n* Ongoing oncological treatment\n* Postoperative radiotherapy for rectal cancer\n* Previous or current cancer in other pelvic organs than the rectum\n* Underlying diarrhoeal disease\n* Inflammatory bowel disease\n* Dementia\n* Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.\n* Inability of patient to use TAI\n* Inability and unwillingness to give informed consent\n* Pregnancy or intention to become pregnant during the trial period",true,"ALL","18 Years",{"count":77,"type":78},114,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).",[84,85],"Low Anterior Resection Syndrome","Rectal Cancer",[84,9,15],"2023-05-01",{"date":89,"type":90},"2023-05-03","ACTUAL",{"date":92,"type":90},"2019-09-17",{"date":94,"type":78},"2026-12",{"name":5,"class":6},1]