A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- Anastomosis leakage rate
研究概览
简要总结
A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer
详细描述
Rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. Surgery remains the main treatment for rectal cancer. Anastomosis leakage (AL) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied.
To achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(IMA) trunk.From the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of IMA. However, there is still a controversy whether IMA should be high ligated or not. The argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of AL. Some studies suggested that a high ligation did not increase the rate of AL. There are still many surgeons prefer the transection of IMA distal to the left colic artery(LCA) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around IMA. Some studies suggests that the preservation of LCA in anterior resection for mid and low rectal cancer is associated with lower rates of AL. Further investigations are needed to resolve the controversy.
In this study, eligible patients will be randomly allocated to receive total mesorectal excision (TME) for rectal cancer either by a high ligation of IMA without preservation of left colic artery or a low ligation of IMA with preservation of left colic artery. Postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for curative surgery over 18 years old;
- •American Society of Anesthesiologists(ASA) grade I-III;
- •Pathological diagnosis of rectal adenocarcinoma;
- •Patients suitable for abdominalperineal resection
- •Informed consent;
- •No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
排除标准
- •Pregnant patient;
- •History of psychiatric disease;
- •Use of systemic steroids;
- •Simultaneous multiple primary colorectal cancer;
- •Preoperative imaging examination results show:
- •Tumor involves the surrounding organs and combined organ resection need to be done;
- •distant metastasis;
- •unable to perform R0 resection;
- •History of any other malignant tumor in recent 5 years;
- •Patients need emergency operation: mechanic ileus, perforation.
研究组 & 干预措施
a high ligation of IMA
total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
干预措施: a high ligation of IMA (Procedure)
a low ligation of IMA
total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
干预措施: a low ligation of IMA (Procedure)
结局指标
主要结局
Anastomosis leakage rate
时间窗: 30 days
次要结局
- operative time(1 day)
- Anastomosis bleeding rate(30 days)
- disease-free survival(5 years)
- local recurrence rate(5 years)
- postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire(5 years)
- number of lymph nodes retrieved(1 day)