Prediction of Abdominal Complications After GastroEnterological Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry

Conditions
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Complication, Anastomotic Leak, Gastrointestinal Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned gastrointestinal surgery. Inform consent received. Exclusion Criteria: Endoscopic surgery. Inform consent denied.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|Patients will undergo routine clinical practice. There is no additional intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Infection rate after gastrectomy. | Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications. | From surgery until discharge, up to 90 days. | 
| Abdominal Infection rate after colorectal surgery. | Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications. | From surgery until discharge, up to 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of Abdominal Infection after Surgery | Severity classification scored based on Clavien-Dindo score, it includes five different scales indicating different severity of the complication. | From surgery until discharge, up to 90 days. | 
| Diagnosis time of Abdominal Complication | 1-3 days after surgery; 4-7 days after surgery; >1wk after surgery | From surgery until discharge, up to 90 days. | 
| Outcome of Abdominal Infection Treatment | Cured before discharge, not cured before discharge, death. | From surgery until discharge, up to 90 days. |