[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"middle-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:middle-rectal-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":21,"type":22},442,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32],"TME","Rectal Cancer Surgery","Low Rectal Cancer","Middle Rectal Cancer","Local Advanced Rectal Cancer",[34,35,36,37,38],"rectal cancer","preventive stoma","randomized trial","low-risk patients","anastomotic leak","RECRUITING","2026-05-11",{"date":42,"type":43},"2026-05-13","ACTUAL",{"date":45,"type":43},"2026-05-05",{"date":47,"type":22},"2027-06-10",{"name":49,"class":50},"ANO Scientific and Practical Club for the Development of Modern Medical Technologies","OTHER",7]