Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- anastomotic leak
研究概览
简要总结
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement.
- •Distal margin of the tumor at least 6 cm form the anal verge
- •Staged as follows prior to neoadjuvant chemoradiation:
- •Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery
排除标准
- •Squamous cell carcinoma
- •Adenocarcinoma Stage T1,
- •T4 with one of the following:
- •with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total)
- •Unresectable primary rectal cancer or Inability to complete R0 resection.
- •Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis
- •Recurrent rectal cancer
- •Previous pelvic malignancy
- •Inability to sign informed consent
- •Pregnancy
结局指标
主要结局
anastomotic leak
时间窗: 30 postoperative days
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
次要结局
- duration of the two operations(Intraoperative)
- Number of overall postoperative complications(30 postoperative days)
研究者
Donato F Altomare
Associate professor
Societa Italiana di Chirurgia ColoRettale