Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- Anastomotic leakage
研究概览
简要总结
The purpose of this study is to explore the different impacts of high and low ligation in laparoscopic rectal interior resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival. In the anterior resection of rectum, the section level of inferior mesenteric artery (IMA) is still a controversial subject between the advocates of high and low ligation. The low ligation is defined as the IMA is ligated below the origin of the left colic artery while the high ligation refers to the IMA is ligated at its origin from the aorta. Nowadays the spread of laparoscopy has encouraged more frequent execution of the high ligation, which appears easier to achieve than the low ligation and also with the advantage of lower anastomosis traction but with the disadvantage of worse vascularization of the stumps as well.
详细描述
It has long been debated that whether to tie off the inferior mesenteric artery (IMA) at its origin or just below the origin of the left colic artery (LCA) of the anterior resection of the rectum. Thus far, no clear consensus has been achieved, and the level of arterial ligation still varies among institutions and patients. In the previous studies, high or low ligation takes advantage on both sides. However, there are still some researches that have demonstrated no significant difference had been found in the incidence of anastomotic leakage and other complications between the high and low ligation groups. Therefore, to provide a clear and definite answer to surgeons of how they should deal with the IMA in laparoscopy rectal surgery. We plan to explore the impacts of high and low tie in laparoscopic anterior rectal resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival by prospective and multi-center clinical trial.
Surgery will be described as follows:
For low ligation group:
- Laparoscopic surgery is performed. Tie the sigmoid artery and superior rectal artery, LCA is preserved. Lymphadenectomy to Apical lymph nodes is performed. Strip the beginning part of upper rectal artery and the first sigmoid artery. Strip the left colic artery until reaching the inferior mesenteric vein (IMV). The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen.
- Vascular ligation level: Left colonic artery needs to be preserved, the rectal artery and the first sigmoid artery are ligated. Ligate inferior mesenteric artery below left colonic artery come across the inferior mesenteric vein level.
For high ligation groups:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 Years to 75 Years (Adult, Senior).
- •Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
- •Tumor located at 4-15 cm from the dentate line.
- •The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
- •Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
- •Anus-saving operation is available.
- •ASA class: I-III.
- •Well tolerate to general anesthesia.
- •ECOG score: 0-
- •Patients - can understand and are willing to take part in the clinical trial.
排除标准
- •Severe cardiovascular disease, uncontrollable infection or other severe complications.
- •Severe mental illness.
- •Suffer with other carcinoma simultaneously or sequentially in 5 years.
- •Familial polyposis coli or Multiple -colorectal tumor.
- •History of abdominal surgery and with severe abdominal adhesions.
- •Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed.
- •Multiple organs resection surgery is needed.
- •Abdominoperineal resection need to be performed.
- •ASA class: IV to V.
- •Pregnant, suckling period or reject to birth control.
- •Patient who unable to go through the clinical trial because of familial,social or religious factors.
- •Refuse to take part in the trial.
- •Patients without an informed consent.
- •Non-compliant patient
- •The patient or their family members want to withdraw from the clinical trial.
- •Loss to follow-up
- •Researchers think the participants need to withdraw from the clinical trial.
结局指标
主要结局
Anastomotic leakage
时间窗: 3 months
Anastomosis leakage rate after surgery, acute or chronic
次要结局
- Early postoperative complications: Anastomotic bleeding, etc.(30 days)
- Anastomosis stenosis rate after surgery(30 days)
- proximal bowel necrosis(3 months)
- proximal bowel stenosis(3 months)
- Characteristics of the division branches of the inferior mesenteric artery in Chinese people(1-2 days)
- Apical Lymph Nodes Positive Rate(14 days)
- Conversion rate to laparotomy(5-years)
- Complications of defunctioning stoma(3 months)
- Mortality rate in 3 months after surgery(3 months)
- Life quality(5-years)
- Micturition function scoring(3 months)
- Sexual function scoring(3 months)
- 5-years overall survival rate(5-years)
- 5-years disease free survival rate(5-years)
研究者
WEIDONG LIU，MD
Head of Department of General Surgery
Xiangya Hospital of Central South University