Prediction of Abdominal Complications After GastroEnterological Surgery

• Conditions: Anastomotic Leak; Complication; Gastrointestinal 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.

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-04
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Planned gastrointestinal surgery.
• Inform consent received.

Exclusion Criteria

• 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)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Xiamen University First Hospital; 🇨🇳 Xiamen, Fujian, China

Guangdong People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affilliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

South Hospital; 🇨🇳 Guanzhou, Guangdong, China

Nanchang University First Hospital; 🇨🇳 Nanchang, Jiangxi, China

Jilin University Second Hospital; 🇨🇳 Changchun, Jilin, China

Dalian Medical University First Hospital; 🇨🇳 Dalian, Liaoning, China

Qinghai University Affiliated Hospital; 🇨🇳 Xining, Qinghai, China

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