Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Overall survival and disease-free survival
研究概览
简要总结
The aim of the investigators' randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colorectal carcinoma.
详细描述
Since the introduction of laparoscopic cholecystectomy in 1987, laparoscopic surgery has been attempted and applied to many surgical operations. Surgeons in Hong Kong began to perform laparoscopic surgery for colorectal carcinoma in early 1992. Early reports of laparoscopic surgery for colorectal carcinoma from Hong Kong and worldwide suggested better short-term clinical outcomes when compared with open surgery, but there were concerns over port site metastases and adequacy of long-term oncological clearance. Besides, only a few randomized trials thus far have compared laparoscopic-assisted and open surgery for rectal carcinoma.
The aim of our randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colonic and rectal carcinoma.
Patients will undergo different types of surgery according to the location of the tumors: right or extended right hemicolectomy for cecal, ascending colon, or hepatic flexure tumors; left hemicolectomy for descending colon tumors; sigmoid colectomy for sigmoid colon tumors; anterior resection for rectosigmoid or upper rectal tumors; low anterior resection with total mesorectal excision for mid- and low rectal tumors; abdominoperineal resection for very low rectal tumors. Patients will be randomly allocated to laparoscopic assisted or conventional open surgery.
Short-term clinical outcome and long-term survival data will be prospectively recorded and compared between the two treatment arms.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed to have colorectal carcinoma at all locations except transverse colon
- •Informed consent available
排除标准
- •Patients with tumor >6 cm in size, or with tumor infiltration to adjacent organs on imagings
- •Patients with previous abdominal surgery near the region of the colorectal surgery
- •Patients with intestinal obstruction or perforation
- •Patients with recurrent disease
- •Patients with synchronous colorectal carcinoma
结局指标
主要结局
Overall survival and disease-free survival
次要结局
- Postoperative analgesic requirements
- Duration of hospital stay
- Direct cost
- Blood loss
- Time to walk independently
- Operative time
- Morbidity and mortality
- Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)
