A Randomized Controlled Clinical Trial to Investigate the Effect of SMA- or SMV- Orientated Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- number of lymph nodes retrieved
研究概览
简要总结
A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach
详细描述
In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind.
In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.
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
- 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 between 18 - 85 years old;
- •American Society of Anesthesiologists(ASA) grade I-III;
- •Preoperative pathological diagnosis of adenocarcinoma;
- •Tumor located at the right colon;
- •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 enhanced CT scan of chest, abdominal and pelvic cavity shows:
- •Tumor involves the surrounding organs and combined organ resection needed 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.
- •Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- •Conversion from laparoscopic surgery to laparotomy;
研究组 & 干预措施
SMA-orientated right hemicoloectomy
SMA-orientated right hemicoloectomy
干预措施: SMA-orientated right hemicoloectomy (Procedure)
SMV-orientated right hemicoloectomy
SMV-orientated right hemicoloectomy
干预措施: SMV-orientated right hemicoloectomy (Procedure)
结局指标
主要结局
number of lymph nodes retrieved
时间窗: 1 day
次要结局
- disease-free survival(3 years)
- overall survival(3 years)
- recurrence-free survival(3 years)
- early complication rate(30 days)
- operative time(1 day)