Randomized Controlled Trial: Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Aged more then 18 years old;
- •Diagnosed as right hemi colonic cancer with colonoscopic biopsy;
- •Without metastasis;
- •No Invasion of surrounding tissues;
- •Limited operation;
- •Underwent laparoscopic radical right hemicolectomy (L-right hemicolectomy);
- •BMI 18~30kg/m2;
- •Without multiple primary tumors;
- •Sign on the Medical informed Consent.
排除标准
- •Simultaneous or 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;
- •Not suitable for laparoscopic surgery;
- •Women during Pregnancy or breast feeding period;
- •Informed consent refusal
研究组 & 干预措施
DML group
The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. In DML group, the dissecting based on CME is performed with dorsal approach and medial approach hybridized.
干预措施: DML group (Procedure)
MLA group
The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. In MLA group,the dissecting based on CME is performed with meidial-to-lateral approach.
干预措施: MLA group (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
次要结局
- The rate of postoperative complication(30 days)
- 3 years overall survival(3 years)
- The rate of local and distant recurrence(3 years)