Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,000
- 试验地点
- 19
- 主要终点
- Abdominal Infection rate after gastrectomy.
研究概览
简要总结
The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. We expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020.
详细描述
All participating hospital will log in on a website based e-CRF system. Researchers need to register the patient information that three time-points: admission, after surgery, after discharge.
The detailed registered information includes:
I. Basic and surgical information:
Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications.
II. Postoperative information:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned gastrointestinal surgery.
- •Inform consent received.
排除标准
- •Endoscopic surgery.
- •Inform consent denied.
结局指标
主要结局
Abdominal Infection rate after gastrectomy.
时间窗: From surgery until discharge, up to 90 days.
Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
Abdominal Infection rate after colorectal surgery.
时间窗: From surgery until discharge, up to 90 days.
Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
次要结局
- Classification of Abdominal Infection after Surgery(From surgery until discharge, up to 90 days.)
- Diagnosis time of Abdominal Complication(From surgery until discharge, up to 90 days.)
- Outcome of Abdominal Infection Treatment(From surgery until discharge, up to 90 days.)
研究者
Ziyu Li, MD
Prof. Dr.
Peking University