Clinical trial NCT03828266: Prediction of Abdominal Complications After GastroEnterological Surgery
Official title: Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication
Anastomotic Leak
Gastrointestinal Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients undergo gastrointestinal (GI) surgery for GI tumor.

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.

Eligibility criteria: Inclusion Criteria:

* Planned gastrointestinal surgery.
* Inform consent received.

Exclusion Criteria:

* Endoscopic surgery.
* Inform consent denied.

Primary outcomes:
measure: Abdominal Infection rate after gastrectomy.
timeFrame: From surgery until discharge, up to 90 days.
measure: Abdominal Infection rate after colorectal surgery.
timeFrame: From surgery until discharge, up to 90 days.
Secondary outcomes:
measure: Classification of Abdominal Infection after Surgery
timeFrame: From surgery until discharge, up to 90 days.
measure: Diagnosis time of Abdominal Complication
timeFrame: From surgery until discharge, up to 90 days.
measure: Outcome of Abdominal Infection Treatment
timeFrame: From surgery until discharge, up to 90 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiamen University First Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affilliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guanzhou
country: China
facility: South Hospital
state: Guangdong
city: Nanchang
country: China
facility: Nanchang University First Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin University Second Hospital
state: Jilin
city: Dalian
country: China
facility: Dalian Medical University First Hospital
state: Liaoning
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao University Affiliated Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Jiao Tong University First Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Hangzhou First Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziyu Li, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: