Randomized Non-inferiority Trial of Selective Splenic Flexure Mobilization for the Formation of Low Colorectal Anastomosis After Total Mesorectal Excision and D3 Paraaortic Lymph Node Dissection in Low Rectal Cancer.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Anastomotic Leakage Rate
研究概览
简要总结
In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated.
The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular sheath of inferior mesenteric artery (IMA) in low anterior resection of the rectum for cancer. This study purpose to demonstrate that low IMA ligation, sparing of left colic artery (LCA) and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%).
详细描述
Although TME is the standard curative operation for rectal cancer patients, who undergo low anterior resection (LAR) or abdominoperineal resection (APR) with a permanent colostomy, the strategy to restore the transit between colon and rectum (in case of LAR) is still debated in literature.
Several studies comparing high-tie with low-tie ligation reported a stage-specific survival benefit for high-tie, but on the other hand recent studies demonstrated that low-tie, without splenic flexure mobilization (SFM), decreases the complexity of the laparoscopic procedure and could reduces the operating time with comparable oncological outcomes.
The method of restorative surgery, after Total Mesorectal Excision (TME), largely depends on the length of the resected part of the colon, that is related to patient's anatomical features and the height of vascular ligation performed during the operation.
In attempt to perform a radical paraaortic lymph node dissection the inferior mesenteric artery (IMA) is usually ligated at its origin and the Arcade of Riolan provides bloody supply to any distal anastomosis. Unfortunately the Arcade of Riolan is an inconstant finding and sometimes (26% of cases) is mandatory to mobilize the splenic flexure to ensure a safe and tension-free anastomosis. SFM is a time-consuming component of LAR, has the additional risk of iatrogenic splenic injury and is very difficult during a laparoscopic resection.
In 2005 was demonstrated that routine SFM is not always necessary during anterior resection for rectal cancer.
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, Outcomes Assessor)
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
- •Histologically proven primary rectal adenocarcinoma located within 15 cm from anal verge not involving internal and/or external sphincter muscle
- •Stage I-III
- •Elective surgical treatment with TME and primary colorectal anastomosis
- •Receive or not receive neoadjuvant radio-chemotherapy
- •Overall health status according to American Society of Anesthesiologists (ASA) classification: I-III
- •Signed informed consent with agreement to attend all study visits
- •The patient is not pregnant
排除标准
- •Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection
- •The patient wants to withdraw from the clinical trial
- •Loss to follow-up
- •Inability to complete all the trial procedures
研究组 & 干预措施
IMA high ligation with routine SFM
Inferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized.
干预措施: Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization (Procedure)
IMA skeletonization and low ligation with selective SFM
Inferior mesenteric artery is ligated below the origin of left colic artery. Splenic flexure is mobilized only if needed.
干预措施: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization (Procedure)
结局指标
主要结局
Anastomotic Leakage Rate
时间窗: 4-6 weeks
The rate of symptomatic and asymptomatic colorectal anastomotic leakage
次要结局
- Splenic flexure mobilization rate(1 day)
- Conversion rate(1 day)
- IMA architectonics(1 day)
- Early postoperative complications rate(30 days)
- Complications of defunctioning stoma(3 month)
- Operating time(1 day)
- Positive Apical Lymph Nodes Rate(30 days)
- Intraoperative complications rate(1 day)
- The postoperative hospital stay(1 month)
- The length of IMA trunk(1 day)
- Specimen morphometry(30 days)