Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- the type of complications and the incidence of it
研究概览
简要总结
Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Even though the development and standardization of gastric cancer surgery, the morbidity of gastric cancer surgery was reported around 20% with less than 1% of mortality in East. In contrast, around 40% of morbidity and 10% of mortality was reported in West. There has been several indexes which can define the complications after surgery, but adapting it into clinical practice is sometimes difficult due to the heterogeneous opinion between surgeons. Thus for clear defining the complications after surgery, consensus between many surgeons and prospective cohort study is necessary. The purpose of this study is collecting the complications data after gastric cancer surgery and defining it with every week meeting by at least 6 or more surgeons' discussion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who had histologically confirmed gastric cancer and are going to underwent gastrectomy
- •age over 20 years with agree to the study
排除标准
- •withdrawal of their agreement
- •vulnerable subjects (ex. pregnancy, disabled to decide by him or herself, cannot understand the study such as mental retardation or foreigner)
结局指标
主要结局
the type of complications and the incidence of it
时间窗: within 30 days after operation, any case of re-admission
the types of complication is classified into as follows: wound complications, intra-abdominal fluid collection or abscess, intra-luminal bleeding, intra-abdominal bleeding, intestinal obstruction, ileus, stricture of anastomosis, anastomosis leak, pancreatitis, pulmonary complications, urinary tract infection, renal dysfunction, hepatic dysfunction, cardiac dysfunction, endocrine dysfunction, miscellaneous complications. Each complication will be graded according to Clavian-Dindo classification. Re-admission or visiting emergency room will be checked and recorded.
次要结局
未报告次要终点