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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 442
- 试验地点
- 7
- 主要终点
- Colorectal anastomotic leak
研究概览
简要总结
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.
详细描述
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.
Patients 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.
After 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.
All patients will undergo minimally invasive TME according to oncological principles (sharp dissection within embryological planes, adequate vascular control, stapled tension-free colorectal anastomosis).
In the stoma group, a diverting ileostomy or colostomy will be created. Closure is planned ≥2-3 months postoperatively if clinically appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Without a preventive stoma
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).
干预措施: Without a preventive stoma (Procedure)
With a preventive stoma
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.
干预措施: With a preventive stoma (Procedure)
结局指标
主要结局
Colorectal anastomotic leak
时间窗: 30 days after main surgery
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.
次要结局
- Postoperative complications(30 days after main surgery)
- Reoperation rate(30 days and 1 year after main surgery)
- Stoma rate(1 year after main surgery)
- Hospital readmissions(30 days after main surgery)
- Quality of life by European Organization for Research and Treatment of Cancer-Cancer30 (EORTC-C30)(30 days and 1 year after surgery)
- Quality of life by European Organization for Research and Treatment of Cancer-ColoRectal 29 (EORTC-CR29)(30 days and 1 year after surgery)
- Low Anterior Resection Syndrome (LARS)(1 year after main surgery)
- Length of hospital stay(until discharge within 90 days)
研究者
Goncharova Vladislava Sergeevna
Director
ANO Scientific and Practical Club for the Development of Modern Medical Technologies