Randomized Controlled Trial to Evaluate High Tie Versus Low Tie of the Inferior Mesenteric Artery in Rectal Anterior Resection for Rectal Cancer Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- Anastomotic leakage rate
研究概览
简要总结
The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is performed in practice. However, there is no evidence that shows effectiveness of this technique.
We conducted a randomized trial that compared between high tie and low tie of the IMA in rectal anterior resection to define an appropriate portion of IMA tying.
详细描述
Patients
- This was a randomized controlled trial conducted at a single institute, which was Yokohama City University Medical Center (Japan).
- 300 patients who underwent anterior resection for rectal cancer were randomly allocated to receive high tie or low tie of the inferior mesenteric artery.
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 around the IMA at its origin was performed in all surgical procedures. Patients who underwent palliative partial excision were not included.
- In the high tie (HT) of the IMA, IMA was separated at its origin from the abdominal aorta.
- In the low tie (LT) of the IMA, IMA was separated after branching to the left colic artery. The lymph node dissection around the IMA at its origin was performed.
Randomization - To balance the operative backgrounds between HT and LT groups, the patients were stratified by the approach of surgery (open or laparoscopic surgery).
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
- •Anterior resection is scheduled for rectal cancer and rectosigmoid cancer preoperatively.
- •Histologically proven adenocarcinoma
- •Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
- •Elective operation
- •Tolerable surgery under general anesthesia
- •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 rectal cancer
- •Pregnant or lactating women
结局指标
主要结局
Anastomotic leakage rate
时间窗: 14 days after surgery
Anastomotic leakage rate is defined as an incontinuity at the anastomosis using circular stapler.
次要结局
- Amount of blood loss(1 day after surgery)
- Overall survival(5 years)
- Operation time(1 day after surgery)
研究者
Shoichi Fujii, MD, PhD
Associate Professor
Yokohama City University Medical Center