A Prospective Randomized Controlled Study of the Short-term Efficacy of Single-hole Plus One-hole Total Laparoscopic Surgery Versus Five-hole Total Laparoscopic Surgery for Distal Gastric Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of complications
研究概览
简要总结
To evaluate the short-term outcomes of single-incision plus one-port laparoscopic surgery (SILS + 1) versus conventional laparoscopic surgery(CLS) for distal gastric cancer whose clinical stage was cT1-3N0-2M0
详细描述
The gastric cancer patients with cT1-3N0-2M0 were randomized at a 1:1 ratio to the CLS group or the SILS+1group, then it will evaluate the short-term outcomes between two groups.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological diagnosis of gastric cancer
- •clinically diagnosed cT1b-3N0-2M0 lesions according to the 8th Edition of the American Joint Committee on Cancer(AJCC) Cancer Staging Manual(measured using abdominal CT)
- •tumor size ≤ 5cm
- •planned to conduct subtotal gastrectomy
排除标准
- •preoperative radiotherapy and chemotherapy
- •tumor perforation
- •severe mental disease
研究组 & 干预措施
single-incision plus one-port laparoscopic surgery(SILS + 1)
It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy
干预措施: single-incision plus one-port laparoscopic surgery (Procedure)
conventional laparoscopic surgery(CLS)
It requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy
干预措施: conventional laparoscopic surgery (Procedure)
结局指标
主要结局
Rate of complications
时间窗: It is within 30 days after surgery
It means the rate of intraoperative and postoperative complications
次要结局
- pain intensity(1-3 days after operation)
- Rate of death(It is within 30 days after surgery)