[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532606":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":57,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":18,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Skane University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"selective approach to defunctioning stoma","EXPERIMENTAL","With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.",[13],"Procedure: selective approach defunctioning stoma",{"label":15,"type":16,"description":17,"interventionNames":18},"routine use of defunctioning stoma","NO_INTERVENTION","With randomisation to this control arm (systematic approach), a defunctioning stoma is constructed using the marked stoma site. A loop ileostomy is fashioned using an ileal loop close to the ileocecal valve, while a loop colostomy can be derived from either the transverse or a redundant left colon.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"PROCEDURE","selective approach defunctioning stoma",[9],[25,29],{"name":26,"affiliation":27,"role":28},"Pamela Buchwald, MD PhD","Skåne University Hospital, Lund University","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Martin Rutegård, MD PhD","Umeå University Hospital, Umeå University Hospital",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Caroline Nilsson, RN","CONTACT","004640331000","caroline.n.nilsson@skane.se",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Skåne University Hospital","RECRUITING","Malmö","Sweden","SE",{"type":46,"coordinates":47},"Point",[48,49],13.00073,55.60587,{"lat":49,"lon":48},[52],{"name":26,"role":35,"phone":18,"phoneExt":18,"email":53},"pamela.buchwald@med.lu.se",{"type":28,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Pamela Buchwald","associate professor, senior consultant surgeon",[58,60,62,64,66,68,71,73],{"name":59,"class":6},"Umeå University",{"name":61,"class":6},"Lund University",{"name":63,"class":6},"Göteborg University",{"name":65,"class":6},"Ersta Hospital, Sweden",{"name":67,"class":6},"Copenhagen University Hospital at Herlev",{"name":69,"class":70},"Linkoeping University","OTHER_GOV",{"name":72,"class":6},"Oslo University Hospital",{"name":74,"class":6},"Örebro University, Sweden","100532606","selective-defunctioning-stoma-in-low-anterior-resection-for-rectal-cancer-100532606",false,"NCT06214988","Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer","SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial","SELSA","Inclusion Criteria:\n\n* Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach\n\nAdditional inclusion criteria for randomised part of the study:\n\n* Patients aged less than 80 years\n* Patients with American Society of Anesthetists' (ASA) fitness grade I or II as determined by the anaesthesiologist or the surgeon\n* Patients without clear radiological signs of distant disease before rectal cancer surgery (previous metastatic surgery is no exclusion criterion)\n* Anastomotic leak risk score of 0-1\n* Willingness to be randomised\n\nExclusion Criteria:\n\n* Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent\n* Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc)\n* Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study\n* Previous pelvic irradiation (due to e.g. gynaecological or urological cancer)\n* Preoperative tumour perforation or pelvic sepsis\n* Beyond TME surgery and\u002For concurrent resection of other organ\n* Concurrent corticosteroid treatment (prednisone-equivalent dosage ≥10 mg daily)\n* Planned postoperative chemotherapy\n* Smoking not completely ceased four weeks before surgery\n* Excessive alcohol consumption with social and medical consequences (as judged by the surgeon in charge) Intraoperative exclusion criteria for randomised part of the study\n\n  -\\>2 staple firings for rectal transection\n* Intraoperative blood loss ≥250 ml for minimally invasive surgery\n* Intraoperative blood loss ≥500 ml for open or converted surgery\n* More than one intraabdominal anastomosis performed\n* Incomplete doughnuts\n* Air-leak test positive\n* Any significant intraoperative adverse event at the discretion of the operating surgeon (e.g. ureterotomy, bowel or tumour perforation, major medical event - pulmonary embolism, cardiac arrhythmia) (Gawria, 2022)\n* TME with anastomosis ultimately not done","ALL","18 Years",{"count":86,"type":87},212,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. The primary outcome is a hybrid so-called textbook outcome; stoma-free survival at two years without major LARS, reflecting a functionally appropriate outcome after low anterior resection for rectal cancer. Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery.",[93],"Rectal Cancer",[95,96,97],"anterior resection","defunctioning stoma","selective approach","2025-05-15",{"date":100,"type":101},"2025-05-21","ACTUAL",{"date":103,"type":101},"2024-09-01",{"date":105,"type":87},"2030-12-31",{"name":5,"class":6},1]