NCT02365896Unknown不适用
Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 主要终点
- postoperative early anastomotic morbidity
研究概览
简要总结
Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •The diagnosis of gastric cancer was confirmed by pathological examination
- •Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
- •No accompany with another cancer
- •ASA I-III
- •Agreement
排除标准
- •Pregnant or suckling period
- •Patients with a history of preoperative chemoradiotherapy
- •Patients with unable to finish D2 lymphadenectomy or R0 resection
- •Laparoscopic surgery contraindications
- •Serious organ disfunction
- •Accompany with serious mental disease
- •Continuous treatment with steroid in 1 month
- •Disagreement
结局指标
主要结局
postoperative early anastomotic morbidity
时间窗: 30 days
次要结局
- Pain score(10 days)
- Quality of life(30 days)
- Flatus time(7 days)
- Postoperative hospital stay(30 days)
- Postoperative inflammation response(10 days)
- Nutrition(30 days)
研究者
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