NCT04573621Unknown不适用
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 518
- 试验地点
- 2
- 主要终点
- Number of participants with pelvic sepsis
研究概览
简要总结
This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.
详细描述
This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:
- pelvic drain
- no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will not know whether the patient received a drain or not
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 18 year-of-age or above
- •Mid or low rectal cancer
- •Anastomosis below the peritoneal reflection
- •Total mesorectal excision (TME)
- •Capability to understand the study
- •Informed consent
排除标准
- •For women, pregnancy
- •Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
- •Life expectancy < 6 months
- •Partial mesorectal excision
- •Abdominoperineal excision
- •Multivisceral resections
- •Emergency surgery
结局指标
主要结局
Number of participants with pelvic sepsis
时间窗: 0-30 days postoperatively
anastomotic leak or pelvic collections clinically or radiologically detected
次要结局
- Time to flatus and bowel movement(0-30 days postoperatively)
- Management of pelvic sepsis(0-30 days postoperatively)
- CT scan or imaging needed(0-30 days postoperatively)
- Number of participants with postoperative ileus(0-30 days postoperatively)
- Length of postperative stay(0-30 days postoperatively or until discharge)
- Diagnostic delay for a leak(0-30 days postoperatively)
- Postoperative complications(0-30 days postoperatively)
- Any complications associated with drain removal after surgery(up to 60 days after surgery)
- Stoma presence at 1-year follow-up(12 months after surgery)
- Late pelvic collections(up to 60 days after surgery)
- Small bowel obstruction(up to 60 days after surgery)
- Quality of life associated with a drain(30 days postoperatively)
研究者
研究点 (2)
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