NCT03828266

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 30, 2019

Last Update Submit

January 31, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Classification of Abdominal Infection after Surgery

    From surgery until discharge, up to 90 days.

  • Diagnosis time of Abdominal Complication

    From surgery until discharge, up to 90 days.

  • Outcome of Abdominal Infection Treatment

    From surgery until discharge, up to 90 days.

Interventions

Patients will undergo routine clinical practice. There is no additional intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Planned gastrointestinal surgery.
  • Inform consent received.

You may not qualify if:

  • Endoscopic surgery.
  • Inform consent denied.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Xiamen University First Hospital

Xiamen, Fujian, China

NOT YET RECRUITING

Guangdong People's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

The First Affilliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

South Hospital

Guanzhou, Guangdong, China

RECRUITING

Nanchang University First Hospital

Nanchang, Jiangxi, China

RECRUITING

Jilin University Second Hospital

Changchun, Jilin, China

RECRUITING

Dalian Medical University First Hospital

Dalian, Liaoning, China

NOT YET RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

Qingdao University Affiliated Hospital

Qingdao, Shandong, China

NOT YET RECRUITING

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Xi'an Jiao Tong University First Hospital

Xi’an, Shanxi, China

RECRUITING

Hangzhou First Hospital

Hangzhou, Zhejiang, China

RECRUITING

Run Run Shaw Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Related Publications (1)

  • Wu Z, Gu T, Wang X, Wei T, Shan F, Li Z, Ji J; PACAGE study group. Surgical quality and health utilization of gastric cancer surgery in China: a post hoc analysis of the Prevalence of Abdominal Complications After Gastroenterological Surgery study. BMJ Surg Interv Health Technol. 2025 Jul 15;7(1):e000332. doi: 10.1136/bmjsit-2024-000332. eCollection 2025.

MeSH Terms

Conditions

Anastomotic LeakGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Ziyu Li, MD PhD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhouqiao Wu, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 4, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations