A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the operation time
研究概览
简要总结
To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.
详细描述
To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.
A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age limits is 18-80 years old;
- •The clinical staging was II,III carcinoma of right colon，located in right-sided colon;
- •The preoperative imaging confirmed that the tumor did not involve adjacent organs;
- •American Society of anesthesiologists (ASA) score less than or equal to Level III;
- •Criteria of performance status karnofsky is greater than or equal to 60.
排除标准
- •The patients' age limits is Less than 18 years old, or more than 80 years old
- •The preoperative imaging confirmed that the tumor involve adjacent organs;
- •The tumor have been finding distant metastases;
- •American Society of anesthesiologists (ASA) score more than 3;
- •Criteria of performance status karnofsky is lower than 60;
- •It is the carcinoma of right colon with multiple colonic polyps Disease;
- •there is a laparoscopic surgery contraindications.
结局指标
主要结局
the operation time
时间窗: up to 36 months
次要结局
- the time to first flatus(up to 36 months)
- the number of lymph nodes dissected(up to 36 months)
- the total blood loss(up to 36 months)
- the average time of ground activities(up to 36 months)
- the intra-operative complication and the post-operative complication(up to 36 months)
研究者
Liao-nan Zou,Prof
professor
Guangdong Provincial Hospital of Traditional Chinese Medicine