Anastomotic Leak, Complication, Gastrointestinal Cancer
Conditions
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.
Interventions
OTHERNo intervention
Patients will undergo routine clinical practice. There is no additional intervention.
Sponsors
Peking University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned gastrointestinal surgery. * Inform consent received.
Exclusion criteria
* Endoscopic surgery. * Inform consent denied.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhouqiao Wu, MD PhD
Outcome results
None listed