Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 22
- 主要终点
- Pelvic sepsis
研究概览
简要总结
After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)
详细描述
After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic sepsis until 30 days between the 2 groups of patients who had a rectal excision with and without pelvic drainage. It is a randomized clinical trial of superiority, multicentric, without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of patients in the groups.
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
- None
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
- •Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment
- •Stapler or manual infraperitoneal anastomosis
- •With or without stoma
- •With bowel preparation
- •Open or laparoscopic approach
- •Stage T1-T4 Nx Mx
- •Age 18 years old or older
- •Information of the patient and signature of informed consent
- •Affiliation to a regime of social insurance
排除标准
- •Colonic cancer (> 15 cm from anal verge)
- •Abdominoperineal resection
- •Associated resection (prostate, seminal bladder, vagina…)
- •Simultaneous liver resection
- •Total coloproctectomy
- •Emergency
- •Infected rectal tumour
- •Pregnant women, suitable to be, or current suckling
- •Persons deprived of freedom or under guardianship
- •Persons under protection of justice
- •Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.
研究组 & 干预措施
Drainage
Rectal excision with aspiration pelvic drainage
干预措施: Laying and management of the drain (strictly randomized arm with drainage) (Procedure)
No drainage
Rectal excision without aspiration pelvic drainage
干预措施: No pelvic drainage (Procedure)
结局指标
主要结局
Pelvic sepsis
时间窗: within the first 30 days after surgery
Pelvic sepsis until 30 days after rectal excision is the primary end point. It is defined as the occurrence of an anastomotic leak revealed by peritonitis or discharge of gas, stools or pus, the vagina or the abdominal wound, and/or a pelvic abscess, between J0 and J30.
次要结局
- Peri-operative mortality(up to 30 days after surgery)
- Overall sepsis(up to 30 days after surgery)
- Surgical morbidity according to Dindo classification(within the first 6 months after surgery)
- Rate of closure of stoma(within the first 6 months after surgery)
- Re-surgery during the hospitalization(during the hospitalization)