Prediction of Abdominal Complications After GastroEnterological Surgery (PACAGE)

January 31, 2019 updated by: Ziyu Li, MD, Peking University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Other: No intervention

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 Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100142
    - Recruiting
    - Peking University Cancer Hospital
    - Contact:
      
      Ziyu Li, M.D.
      
      Email: ligregory369@hotmail.com
    - Contact:
      
      Zhouqiao Wu, M.D.
      
      Email: wuzhouqiao@gmail.com
- Fujian
  - Fuzhou, Fujian, China
    - Not yet recruiting
    - Fujian Medical University Union Hospital
    - Contact:
      
      Zhaohui Zheng
  - Xiamen, Fujian, China
    - Not yet recruiting
    - Xiamen University First Hospital
    - Contact:
      
      Jun You
- Guangdong
  - Guangzhou, Guangdong, China
    - Not yet recruiting
    - Guangdong People's Hospital
  - Guangzhou, Guangdong, China
    - Recruiting
    - The First Affilliated Hospital, Sun Yat-sen University
    - Contact:
      
      Wu Song
      
      Email: denisewei@126.com
  - Guanzhou, Guangdong, China
    - Recruiting
    - South Hospital
    - Contact:
      
      Jiang Yu
      
      Email: balbc@163.com
- Jiangxi
  - Nanchang, Jiangxi, China
    - Recruiting
    - Nanchang University First Hospital
    - Contact:
      
      Zhengrong Li
- Jilin
  - Changchun, Jilin, China
    - Recruiting
    - Jilin University Second Hospital
    - Contact:
      
      Jiaming Zhu
- Liaoning
  - Dalian, Liaoning, China
    - Not yet recruiting
    - Dalian Medical University First Hospital
    - Contact:
      
      Pin Liang
- Qinghai
  - Xining, Qinghai, China
    - Recruiting
    - Qinghai University Affiliated Hospital
    - Contact:
      
      Su Yan, MD
      
      Email: yansu3598507@163.com
- Shandong
  - Jinan, Shandong, China
    - Recruiting
    - Shandong Provincial Hospital
    - Contact:
      
      Changqing Jing
  - Qingdao, Shandong, China
    - Not yet recruiting
    - Qingdao University Affiliated Hospital
    - Contact:
      
      Zhaojian Niu
- Shanghai
  - Shanghai, Shanghai, China
    - Not yet recruiting
    - Zhongshan Hospital
    - Contact:
      
      Fenglin Liu
  - Shanghai, Shanghai, China
    - Recruiting
    - Ruijin Hospital
  - Shanghai, Shanghai, China
    - Not yet recruiting
    - Fudan University Cancer Hospital
  - Shanghai, Shanghai, China
    - Not yet recruiting
    - Huashan Hospital
    - Contact:
      
      Hankun Hao
- Shanxi
  - Xi'an, Shanxi, China
    - Recruiting
    - Xi'an Jiao Tong University First Hospital
    - Contact:
      
      Lin Fan
- Zhejiang
  - Hangzhou, Zhejiang, China
    - Recruiting
    - Hangzhou First Hospital
  - Hangzhou, Zhejiang, China
    - Not yet recruiting
    - Run Run Shaw Hospital
    - Contact:
      
      Linghua Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients undergo gastrointestinal (GI) surgery for GI tumor.

Description

Inclusion Criteria:

Planned gastrointestinal surgery.
Inform consent received.

Exclusion Criteria:

Endoscopic surgery.
Inform consent denied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Infection rate after gastrectomy. Time Frame: From surgery until discharge, up to 90 days.	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. Time Frame: From surgery until discharge, up to 90 days.	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 Time Frame: 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.	From surgery until discharge, up to 90 days.
Diagnosis time of Abdominal Complication Time Frame: From surgery until discharge, up to 90 days.	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 Time Frame: From surgery until discharge, up to 90 days.	Cured before discharge, not cured before discharge, death.	From surgery until discharge, up to 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

Principal Investigator: Ziyu Li, MD PHD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)