Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery in Elderly Colorectal Cancer Patients Who Were 75 Years Old or Over
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Early complication rate
研究概览
简要总结
Elderly patients have poorer preoperative conditions than younger patients. Therefore, minimally invasive surgery should be an effective treatment method for elderly patients. The investigators conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in elderly patients who were 75 years old or over. The purpose of the present study was to clarify the effect of laparoscopic surgery in elderly patients. In our hypothesis of this trial, laparoscopic surgery is superior to conventional open surgery in short-term results, and same outcome in long -term results. Therefore, laparoscopic surgery would be recommended as standard procedure in an elderly colorectal patient.
详细描述
Patients
- This was a randomized controlled trial conducted at a single institute, which was Yokohama City University Medical Center (Japan).
- 200 patients were age of 75 years old or over were randomly allocated to receive laparoscopic surgery or conventional open surgery.
Surgical procedures
- All surgical procedures were performed by one specialized colorectal treatment team. The laparoscopic surgeries were performed by a surgeon who passed the skill accreditation system for laparoscopic gastroenterological surgery was established by the Japanese Society for Endoscopic Surgery (JSES), and all open surgeries were performed under the supervision of these skillful surgeons.
- All operations were performed according to the standard radical cure procedure described in the seventh edition of the Japanese General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus. That is, intestinal excision with lymph node dissection that separated the feeding blood vessel at its origin was performed in all surgical procedures. Patients who underwent palliative partial excision were not included.
- In the laparoscopic surgery, a medial-to-lateral approach was performed in all patients.
- In the conventional open surgery, the first procedure was done in lateral approach. The reconstruction techniques were the same as those used in laparoscopic surgery.
Randomization
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 75 years old or over
- •Histologically proven adenocarcinoma
- •Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
- •Elective operation
- •Tolerable surgery under general anesthesia
- •No bulky tumor larger than 8cm in diameter
- •No history of laparotomy for colorectal resection except appendectomy
- •Provided written informed consent
排除标准
- •Synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
- •Multiple colorectal cancer that needs reconstruction two or more times
- •Acute intestinal obstruction or perforation due to colorectal cancer
- •Lower rectal cancer that required pelvic side wall lymphadenectomy
- •Pregnant or lactating women
结局指标
主要结局
Early complication rate
时间窗: 30 days after surgery
All complication due to surgical procedure within 30 days after surgery
次要结局
- Overall survival(5 years)
- Health-related QOL score(1 year after surgery)
- Recurrence-free survival(3 years)
- Length of postoperative hospital stay(9 days)
研究者
Shoichi Fujii, MD, PhD
Associate Professor
Yokohama City University Medical Center