Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The 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. The 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. Participants 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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Advanced Rectal Cancer | — | UNRESOLVED | — |
| Low Rectal Cancer | — | UNRESOLVED | — |
| Middle Rectal Cancer | — | UNRESOLVED | — |
| Rectal Cancer Surgery | — | UNRESOLVED | — |
| TME | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| With a preventive stoma | Procedure | — | UNRESOLVED |
| Without a preventive stoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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. If 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years; * Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0); * Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy; * Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI); * Planned radical minimally invasive (laparoscopic/robot-assisted) intervention with TME and formation of primary colorectal/colonanal anastomosis; * Adequate hematologic function: hemoglobin ≥100 g/L, leukocytes \>4 × 10\^9/L, platelets \>100 × 10\^9/L; * Adequate renal function: serum creatinine \<150 µmol/L; * Adequate hepatic function: AST/ALT \<100 U/L; * Predicted risk of anastomotic leakage ≤10% (AFOR 0-1). Exclusion Criteria: * Age ≥80 years; * Presence of a pre-existing diverting ileostomy or colostomy; * Peritumoral abscess or tumor perforation; * Distant metastases (M1) identified preoperatively and/or intraoperatively; * Synchronous or metachronous malignancy; * Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer); * Evidence of malnutrition (serum albumin \<34 g/L); * 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; * Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively; * Predicted risk of anastomotic leakage \>10% (AFOR 2-6).
References
Publications (0)
Data not yet available