Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 28
- 主要终点
- Disease-free survival at 3 years
研究概览
简要总结
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
详细描述
This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.
Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.
The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.
All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.
Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.
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
- •American Society of Anesthesiologists(ASA) grade I-III.
- •Right colon cancer (*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
- •Informed consent
排除标准
- •Age > 85 years old.
- •T4b, any N
- •Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
- •American Society of Anesthesiologists(ASA) grade IV.
- •History of cancer in recent 5 years.
- •Need for Emergency surgery.
- •Infectious disease requiring treatment.
- •Pregnancy.
- •Use of systemic steroids.
- •No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
结局指标
主要结局
Disease-free survival at 3 years
时间窗: 3 Years.
The length of time after surgery without any signs or symptoms of local or distant recurrence.
次要结局
- Safety-Operative time.(Intraoperative)
- Early postoperative complications.(30 postoperative days.)
- Overall Survival at 5 years.(5 Years.)
- Overall Survival at 3 years(3 Years.)
- Disease-free survival.(5 Years.)
- Safety-Intraoperative blood loss.(Intraoperative)
- Late postoperative complications.(From the 31st postoperative days to the end of the study.)
- Safety- Length of stay.(30 Days.)
- Safety- Postoperative mortality rate.(30 Days.)
- Safety-Intraoperative blood transfusion.(Intraoperative)
- Safety- Intraoperative Complications.(Intraoperative)
- Other Oncologic outcomes.(30 Days.)