Prediction of Abdominal Complications After GastroEnterological Surgery
- Conditions
- Anastomotic LeakComplicationGastrointestinal Cancer
- Registration Number
- NCT03828266
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
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:
Primary lesion histological type, margin, pathological stage (pTNM); other complications, postoperative death and discharge time, CRP, PCT, WBC levels.
III. Abdominal Infection information:
Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4000
- Planned gastrointestinal surgery.
- Inform consent received.
- Endoscopic surgery.
- Inform consent denied.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abdominal Infection rate after gastrectomy. 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. From surgery until discharge, up to 90 days. Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
- Secondary Outcome Measures
Name Time Method Classification of Abdominal Infection after Surgery From surgery until discharge, up to 90 days. Severity classification scored based on Clavien-Dindo score, it includes five different scales indicating different severity of the complication.
Diagnosis time of Abdominal Complication From surgery until discharge, up to 90 days. 1-3 days after surgery; 4-7 days after surgery; \>1wk after surgery
Outcome of Abdominal Infection Treatment From surgery until discharge, up to 90 days. Cured before discharge, not cured before discharge, death.
Trial Locations
- Locations (19)
South Hospital
🇨🇳Guanzhou, Guangdong, China
Dalian Medical University First Hospital
🇨🇳Dalian, Liaoning, China
Qinghai University Affiliated Hospital
🇨🇳Xining, Qinghai, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Qingdao University Affiliated Hospital
🇨🇳Qingdao, Shandong, China
Xi'an Jiao Tong University First Hospital
🇨🇳Xi'an, Shanxi, China
Hangzhou First Hospital
🇨🇳Hangzhou, Zhejiang, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Jilin University Second Hospital
🇨🇳Changchun, Jilin, China
Nanchang University First Hospital
🇨🇳Nanchang, Jiangxi, China
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Xiamen University First Hospital
🇨🇳Xiamen, Fujian, China
The First Affilliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China
Guangdong People's Hospital
🇨🇳Guangzhou, Guangdong, China
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China
Huashan Hospital
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China