Prediction of Abdominal Complications After GastroEnterological Surgery

Gastrointestinal Cancer Clinical Trial

— PACAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828266
• Other study ID #: 2018YJZ56
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Peking University
• Contact: Zhouqiao Wu, MD PhD
• Phone: 0086-10-88196606
• Email: wuzhouqiao[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned gastrointestinal surgery.

• Inform consent received.

Exclusion Criteria:

• Endoscopic surgery.

• Inform consent denied.

Related Conditions & MeSH terms

• Anastomotic Leak
• Complication
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• No intervention
Patients will undergo routine clinical practice. There is no additional intervention.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing
China	Jilin University Second Hospital	Changchun	Jilin
China	Dalian Medical University First Hospital	Dalian	Liaoning
China	Fujian Medical University Union Hospital	Fuzhou	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	Hangzhou First Hospital	Hangzhou	Zhejiang
China	Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	Nanchang University First Hospital	Nanchang	Jiangxi
China	Qingdao University Affiliated Hospital	Qingdao	Shandong
China	Fudan University Cancer Hospital	Shanghai	Shanghai
China	Huashan Hospital	Shanghai	Shanghai
China	Ruijin Hospital	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai
China	Xi'an Jiao Tong University First Hospital	Xi'an	Shanxi
China	Xiamen University First Hospital	Xiamen	Fujian
China	Qinghai University Affiliated Hospital	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Infection rate after gastrectomy.	Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.	From surgery until discharge, up to 90 days.
Primary	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	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.
Secondary	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.
Secondary	Outcome of Abdominal Infection Treatment	Cured before discharge, not cured before discharge, death.	From surgery until discharge, up to 90 days.