Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative stay
研究概览
简要总结
This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.
详细描述
When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.
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)
盲法说明
the Outcomes Assessor would not know which approach the patient received.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •aged 18-80 years old, no gender limitation;
- •primary gastric cancer and planed for distal gastrectomy;
排除标准
- •patients with total or proximal gastrectomy;
- •patients with distant metastasis.
结局指标
主要结局
postoperative stay
时间窗: about one week to one month from the finish of surgery
the time from the finish of surgery to discharge
次要结局
- Survival(3 year)
研究者
Liu Liu
Clinical professor
The First Affiliated Hospital of University of Science and Technology of China