Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 6:36 AM
Study NCT ID:
NCT07463261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 442}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorectal anastomotic leak', 'timeFrame': '30 days after main surgery', 'description': 'If anastomotic leakage is suspected in the postoperative period defined by worsening abdominal pain (\\>5-point increase on the Visual Analog Scale), signs of peritonitis, drain output containing fibrin or intestinal content, or radiologic findings suggestive of leakage on contrast-enhanced CT of the abdomen and pelvis (with or without proctography) and/or findings at diagnostic laparoscopy. Diagnostic and/or therapeutic measures will be undertaken to confirm or rule out the complication.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days after main surgery', 'description': 'Postoperative complications will be classified according to the Clavien-Dindo classification'}, {'measure': 'Reoperation rate', 'timeFrame': '30 days and 1 year after main surgery', 'description': 'During a clinic visit or by telephone interview'}, {'measure': 'Stoma rate', 'timeFrame': '1 year after main surgery', 'description': 'During a clinic visit or by telephone interview'}, {'measure': 'Hospital readmissions', 'timeFrame': '30 days after main surgery', 'description': "The frequency of repeated admissions to this or other hospitals after the patient's discharge"}, {'measure': 'Quality of life by European Organization for Research and Treatment of Cancer-Cancer30 (EORTC-C30)', 'timeFrame': '30 days and 1 year after surgery', 'description': 'EORTC-C30 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}, {'measure': 'Quality of life by European Organization for Research and Treatment of Cancer-ColoRectal 29 (EORTC-CR29)', 'timeFrame': '30 days and 1 year after surgery', 'description': 'EORTC-CR29 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.'}, {'measure': 'Low Anterior Resection Syndrome (LARS)', 'timeFrame': '1 year after main surgery', 'description': 'At 1 year, assessment of Low Anterior Resection Syndrome (LARS) will be performed during a clinic visit or by telephone interview.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'until discharge within 90 days', 'description': 'total days in hospital'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'preventive stoma', 'randomized trial', 'low-risk patients', 'anastomotic leak'], 'conditions': ['TME', 'Rectal Cancer Surgery', 'Low Rectal Cancer', 'Middle Rectal Cancer', 'Local Advanced Rectal Cancer']}, 'descriptionModule': {'briefSummary': '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 \\<10% according to the study risk model.', 'detailedDescription': 'This study is a multicenter randomized controlled non-inferiority trial evaluating the safety of omitting routine diverting stoma formation in low-risk patients undergoing total mesorectal excision (TME) for mid- and low-rectal cancer.\n\nPatients with a predicted risk of colorectal anastomotic leakage (AL) ≤10% will be enrolled across 7 accredited centers. Local Ethics Committee approval has been obtained at each site. The protocol follows the SPIRIT 2025 recommendations.\n\nAfter informed consent, patients will be randomized 1:1 to "with preventive stoma" and "without preventive stoma". Stratified block randomization (block sizes 2, 4, or 6) will be used, stratified by center and sex. Allocation will be computer-generated (R software). No blinding will be performed. Cross-over to stoma formation in the no-stoma group is permitted in case of intraoperative safety concerns.\n\nAll patients will undergo minimally invasive TME according to oncological principles (sharp dissection within embryological planes, adequate vascular control, stapled tension-free colorectal anastomosis).\n\nIn the stoma group, a diverting ileostomy or colostomy will be created. Closure is planned ≥2-3 months postoperatively if clinically appropriate.\n\nPostoperative care follows institutional standards. Complications will be graded according to the Clavien-Dindo classification. Patients will be followed for 1 year with clinical visits (or telephone follow-up) at 30 days and every 3 months. Imaging and colonoscopy will be performed according to clinical guidelines. Quality-of-life assessments and LARS score will be obtained at 30 days and 1 year.\n\nRisk Prediction Model. Eligibility is determined using a gradient boosted model (Bernoulli loss) developed on retrospective data. The model demonstrated AUC 0.93 with predefined cutoff risk of 10% (sensitivity 74%, specificity 91%). Model development and validation were performed using R software.\n\nSample Size and Statistical Analysis. Assuming a baseline AL rate of 15% in the stoma group, a non-inferiority margin of 10%, one-sided α=2.5%, 80% power, and 10% dropout rate, 442 patients (221 per group) are required. The primary analysis will follow the intention-to-treat (ITT) principle. A binomial logistic regression model will estimate risk difference with 95% confidence intervals using clustered robust standard errors by center. Non-inferiority will be concluded if the upper bound of the confidence interval does not cross the predefined margin. Sensitivity analyses will include per-protocol and instrumental variable approaches. Missing data for secondary outcomes will be handled using multiple imputation (MCAR assumption).\n\nInterim Safety Analysis. A safety analysis will be conducted after enrollment of 50 patients per group. If unacceptable differences in AL rates are observed, early termination may be considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years;\n* Primary rectal cancer staged as cT1-4aN0-3M0;\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/or pelvic MRI);\n* Planned radical minimally invasive surgery (laparoscopic or robotic-assisted procedure);\n* Adequate hematologic function: hemoglobin ≥100 g/L, leukocytes \\>4 × 10\\^9/L, platelets \\>100 × 10\\^9/L;\n* Adequate renal function: serum creatinine \\<150 µmol/L;\n* Adequate hepatic function: AST/ALT \\<100 U/L;\n* Predicted risk of anastomotic leakage ≤10% according to the study-specific risk model developed from retrospective data.\n\nExclusion Criteria:\n\n* Age ≥70 years;\n* Presence of a pre-existing diverting ileostomy or colostomy;\n* Peritumoral abscess or tumor perforation;\n* Distant metastases (M1) identified preoperatively and/or 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 \\<34 g/L);\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/neurological disorders impairing the ability to provide informed consent;\n* Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively;\n* Predicted risk of anastomotic leakage \\>10% according to the study risk model.'}, 'identificationModule': {'nctId': 'NCT07463261', 'acronym': 'RELOAD', 'briefTitle': 'REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department', 'organization': {'class': 'OTHER', 'fullName': 'ANO Scientific and Practical Club for the Development of Modern Medical Technologies'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '07/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Without a preventive stoma', 'description': "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/or if patient safety is deemed at risk, a diverting stoma may be created at the surgeon's discretion (cross-over).", 'interventionNames': ['Procedure: Without a preventive stoma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'With a preventive stoma', 'description': '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.', 'interventionNames': ['Procedure: With a preventive stoma']}], 'interventions': [{'name': 'Without a preventive stoma', 'type': 'PROCEDURE', 'description': '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).', 'armGroupLabels': ['Without a preventive stoma']}, {'name': 'With a preventive stoma', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['With a preventive stoma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vladislava S Goncharova, Ms.', 'role': 'CONTACT', 'email': 'vladislava.26@mail.ru', 'phone': '+7 900 468 9026'}, {'name': 'Nikita N Burlov, Dr.', 'role': 'CONTACT', 'email': 'dikefsound@gmail.com', 'phone': '+79819430019'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANO Scientific and Practical Club for the Development of Modern Medical Technologies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head', 'investigatorFullName': 'Goncharova Vladislava Sergeevna', 'investigatorAffiliation': 'ANO Scientific and Practical Club for the Development of Modern Medical Technologies'}}}}