Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery in Transverse and Descending Colon Cancer Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Early complication rate
研究概览
简要总结
The long-term results of several large-scale prospective randomized trials that compared laparoscopic-assisted and open colectomy for colon cancer were published in the past decade. The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to compare oncological outcomes between patients who underwent laparoscopic or open surgery for advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were concerning tumor site in transverse and descending colon. The reason of exclusion was that laparoscopic procedure was difficult in transverse and descending colon cancers. However, laparoscopic surgery for transverse and descending colon cancer was performed clinically. We conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in in transverse and descending colon cancer. The purpose of the present study was to clarify the safety and feasibility of laparoscopic surgery on in transverse and descending colon cancer patients.
详细描述
Patients
- This was a randomized controlled trial conducted at a single institute, which was Yokohama City University Medical Center (Japan).
- 80 patients who had transverse colon or descending colon cancer 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 - To balance the operative backgrounds between the laparoscopic and the conventional open surgery groups, the patients were stratified by the tumor location (transverse colon, descending colon).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20 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: within the first 30 days after surgery
Early complication is defined as a complication that occured between the finish of the surgery and postoperative day 30.
次要结局
- Length of postoperative hospital stay(10 days)
- Recurrence-free survival(5 years)
- Overall survival(5 years)
- Health-related QOL score(1 year after surgery)
研究者
Shoichi Fujii, MD, PhD
Associate Professor
Yokohama City University Medical Center