Prediction of Abdominal Complications After GastroEnterological Surgery

NCT ID: NCT03828266

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Complication Anastomotic Leak Gastrointestinal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Planned gastrointestinal surgery.
* Inform consent received.

Exclusion Criteria

* Endoscopic surgery.
* Inform consent denied.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Ziyu Li, MD

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziyu Li, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Xiamen University First Hospital

Xiamen, Fujian, China

Site Status NOT_YET_RECRUITING

Guangdong People's Hospital

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The First Affilliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

South Hospital

Guanzhou, Guangdong, China

Site Status RECRUITING

Nanchang University First Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

Jilin University Second Hospital

Changchun, Jilin, China

Site Status RECRUITING

Dalian Medical University First Hospital

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Site Status NOT_YET_RECRUITING

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Xi'an Jiao Tong University First Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Hangzhou First Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Zhouqiao Wu, MD PhD

Role: CONTACT

0086-10-88196606

Facility Contacts

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Ziyu Li, M.D.

Role: primary

Zhouqiao Wu, M.D.

Role: backup

Zhaohui Zheng

Role: primary

Jun You

Role: primary

Yong Li

Role: primary

Wu Song

Role: primary

Jiang Yu

Role: primary

Zhengrong Li

Role: primary

Jiaming Zhu

Role: primary

Pin Liang

Role: primary

Su Yan, MD

Role: primary

Changqing Jing

Role: primary

Zhaojian Niu

Role: primary

Hua Huang

Role: primary

Hankun Hao

Role: primary

Lu Zang

Role: primary

Fenglin Liu

Role: primary

Lin Fan

Role: primary

Jian Zhang

Role: primary

Linghua Zhu

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40671863 (View on PubMed)

Other Identifiers

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2018YJZ56

Identifier Type: -

Identifier Source: org_study_id

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