Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Total number of lymph nodes and lymph node ratio.
研究概览
简要总结
A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid 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
- Single (Participant)
盲法说明
The patient does not know the group to which it has been assigned.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer.
- •Age ≥ 18 years and <80 years.
- •Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy.
- •Any T, any N, M
- •Intention of resection R
- •Informed consent signed by the patient and the investigator.
排除标准
- •Colorectal tumor with histology other than adenocarcinoma or adenoma.
- •Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon.
- •Metastatic disease (M1).
- •History of colorectal cancer surgery, different from a local excision.
- •Inflammatory bowel disease with anatomopathological confirmation.
- •Patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent.
- •Inability to read or understand any of the languages of the informed consent (Catalan, Spanish).
- •Another synchronous malignant disease.
- •Emergency surgery.
结局指标
主要结局
Total number of lymph nodes and lymph node ratio.
时间窗: 30 days
To compare the total number of lymph nodes resected and the lymph node ratio (defined as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.
次要结局
- Local recurrence(5 years)
- Survival(5 years)
研究者
Pere Planellas Giné
Principal investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta