[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628563":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":125,"collaborators":25,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":25,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":153,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"ANO Scientific and Practical Club for the Development of Modern Medical Technologies","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Without a preventive stoma","EXPERIMENTAL","In the no-stoma group, a diverting stoma will not be created provided there are no intraoperative complications and surgical safety principles are maintained.\n\nIf intraoperative findings suggest a high risk of anastomotic leakage such as a positive air leak test of the colorectal anastomosis, bowel perforation, use of three or more linear stapler cartridges, blood loss \\>300 mL, impaired bowel wall perfusion, or tension at the anastomotic site and\u002For if patient safety is deemed at risk, a diverting stoma may be created at the surgeon's discretion (cross-over).",[13],"Procedure: Without a preventive stoma",{"label":15,"type":16,"description":17,"interventionNames":18},"With a preventive stoma","ACTIVE_COMPARATOR","In the stoma group, a diverting ileostomy or colostomy will be created at the end of the surgical procedure in the right or left lateral abdominal wall, according to the technique routinely used at each participating center. Stoma closure will be planned according to standard practice (no earlier than 2-3 months after surgery), provided there are no contraindications.",[19],"Procedure: With a preventive stoma",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","At the conclusion of total mesorectal excision (TME), a diverting ileostomy or transverse colostomy will be created at the discretion of the operating surgeon. The pelvic peritoneum over the anastomotic site will be closed, and a pelvic drain will be placed (the type of drain will be determined by the operating surgeon).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The operating surgeon will follow the standard practice adopted at the respective center and will create either a diverting ileostomy or transverse colostomy at their discretion. The pelvic peritoneum will not be closed. Placement of a percutaneous pelvic drain adjacent to the anastomotic site is mandatory.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Vladislava S Goncharova, Ms.","CONTACT","+7 900 468 9026","vladislava.26@mail.ru",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Nikita N Burlov, Dr.","+79819430019","dikefsound@gmail.com",[40,58,68,77,89,101,113],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Moscow City Oncology Hospital No. 62 of the Moscow Department of Health","RECRUITING","Moscow","143423","Russia","RU",{"type":48,"coordinates":49},"Point",[50,51],37.61781,55.75204,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":56,"phoneExt":25,"email":57},"Ilya Chernikovsky","+79216576756","odindra@mail.ru",{"facility":59,"status":42,"city":43,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation",{"type":48,"coordinates":61},[50,51],{"lat":51,"lon":50},[64],{"name":65,"role":32,"phone":66,"phoneExt":25,"email":67},"Artem Goncharov","+79990112121","goncharovartemleo@gmail.com",{"facility":69,"status":42,"city":43,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"State Budgetary Institution of Healthcare of the city of Moscow \"Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow\"",{"type":48,"coordinates":71},[50,51],{"lat":51,"lon":50},[74],{"name":75,"role":32,"phone":66,"phoneExt":25,"email":76},"Vischeslav Aliev","afandiali76@gmail.com",{"facility":78,"status":42,"city":79,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"State Autonomous Healthcare Institution of Nizhny Novgorod Region \"Research Institute of Clinical Oncology \"Nizhny Novgorod Regional Clinical Oncology Dispensary\"\"","Nizhny Novgorod",{"type":48,"coordinates":81},[82,83],44.00205,56.32867,{"lat":83,"lon":82},[86],{"name":87,"role":32,"phone":66,"phoneExt":25,"email":88},"Gleb Khrykov","ghrykov@mail.ru",{"facility":90,"status":42,"city":91,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Leningrad Regional Clinical Hospital","Saint Petersburg",{"type":48,"coordinates":93},[94,95],30.31413,59.93863,{"lat":95,"lon":94},[98],{"name":99,"role":32,"phone":66,"phoneExt":25,"email":100},"Alexey Smirnov","oncsmirnov@yandex.ru",{"facility":102,"status":42,"city":103,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Republican clinical oncological center","Ufa",{"type":48,"coordinates":105},[106,107],55.96779,54.74306,{"lat":107,"lon":106},[110],{"name":111,"role":32,"phone":66,"phoneExt":25,"email":112},"Rustem Ayupov","ru2003@bk.ru",{"facility":114,"status":42,"city":115,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Sverdlovsk Regional Oncological Center","Yekaterinburg",{"type":48,"coordinates":117},[118,119],60.61529,56.85733,{"lat":119,"lon":118},[122],{"name":123,"role":32,"phone":66,"phoneExt":25,"email":124},"Nikolay Makhotin","n.v.mahotin@mail.ru",{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Goncharova Vladislava Sergeevna","Director","100628563","results-of-low-anterior-resections-with-or-without-preventive-stoma-in-nonemergency-department-100628563",false,"NCT07463261","REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department","Results of Anastomotic Leak After Low Anterior Resection With or Without Preventive Stoma for Rectal Cancer in Low-risk Patients in Nonemergency Departments (RELOAD): Protocol of Multicenter Randomized Controlled Non-inferiority Trial","RELOAD","Inclusion Criteria:\n\n* Age \\>18 years;\n* Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);\n* Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;\n* Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and\u002For pelvic MRI);\n* Planned radical minimally invasive (laparoscopic\u002Frobot-assisted) intervention with TME and formation of primary colorectal\u002Fcolonanal anastomosis;\n* Adequate hematologic function: hemoglobin ≥100 g\u002FL, leukocytes \\>4 × 10\\^9\u002FL, platelets \\>100 × 10\\^9\u002FL;\n* Adequate renal function: serum creatinine \\\u003C150 µmol\u002FL;\n* Adequate hepatic function: AST\u002FALT \\\u003C100 U\u002FL;\n* Predicted risk of anastomotic leakage ≤10% (AFOR 0-1).\n\nExclusion Criteria:\n\n* Age ≥80 years;\n* Presence of a pre-existing diverting ileostomy or colostomy;\n* Peritumoral abscess or tumor perforation;\n* Distant metastases (M1) identified preoperatively and\u002For intraoperatively;\n* Synchronous or metachronous malignancy;\n* Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);\n* Evidence of malnutrition (serum albumin \\\u003C34 g\u002FL);\n* Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive pulmonary disease, chronic kidney disease stage 4-5), type 1 or type 2 diabetes mellitus, or psychiatric\u002Fneurological disorders impairing the ability to provide informed consent;\n* Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and\u002For intraoperatively;\n* Predicted risk of anastomotic leakage \\>10% (AFOR 2-6).","ALL","18 Years","70 Years",{"count":141,"type":142},442,"ESTIMATED","INTERVENTIONAL",[145],"NA","The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.\n\nThe primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group.\n\nThe secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year.\n\nParticipants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage \\\u003C10% according to the study risk model.",[148,149,150,151,152],"TME","Rectal Cancer Surgery","Low Rectal Cancer","Middle Rectal Cancer","Local Advanced Rectal Cancer",[154,155,156,157,158],"rectal cancer","preventive stoma","randomized trial","low-risk patients","anastomotic leak","2026-05-11",{"date":161,"type":162},"2026-05-13","ACTUAL",{"date":164,"type":162},"2026-05-05",{"date":166,"type":142},"2027-06-10",{"name":5,"class":6},7]