A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,044
- 试验地点
- 41
- 主要终点
- locoregional recurrence rate
研究概览
简要总结
COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.
详细描述
The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy.
If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%.
Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •solitary rectal cancer observed at colonoscopy or on barium X-ray
- •no evidence of distant metastases
- •distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
- •suitable for elective surgical resection
- •informed consent
排除标准
- •T1 tumors treated by locl excision
- •T4 tumors
- •patients under 18 years of age
- •signs of acute intestinal obstruction
- •more than one colorectal tumor
- •Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
- •active crohn's or active ulcerative colitis
- •scheduled need for other synchronous colon surgery
- •preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
- •preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
- •other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- •absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
- •pregnancy
结局指标
主要结局
locoregional recurrence rate
时间窗: 3 years post operatively
次要结局
- out-of-hospital postoperative costs(seven years)
- overall survival(three, five and seven years post-operatively)
- duration of in-hospital stay(post-operative)
- survival free of cancer recurrence(three, five and seven years post-operatively)
- port-site and wound-site recurrences(annually for seven years)
- macroscopic evaluation of the resected specimen(post-operative)
- distant metastases rate(annually for seven years)
- postoperative health related quality of life,including standardized questionnaires on sexual and bladder function(weekly for 8 weeks)
- operative mortality and morbidity(8 week or in-hospital)
- duration of absence of work(8 weeks and 6 months post-operatively)
- in-hospital direct and indirect costs(seven years)