- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828266
Prediction of Abdominal Complications After GastroEnterological Surgery (PACAGE)
Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zhouqiao Wu, MD PhD
- Phone Number: 0086-10-88196606
- Email: wuzhouqiao@gmail.com
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Planned gastrointestinal surgery.
- Inform consent received.
Exclusion Criteria:
- Endoscopic surgery.
- Inform consent denied.
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Ziyu Li, MD PHD, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018YJZ56
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anastomotic Leak
-
Freek DaamsSAS InstituteRecruitingAnastomotic Leak | Anastomotic Leak Rectum | Anastomotic Complication | Anastomotic Leak Large IntestineNetherlands
-
Fundación Pública Andaluza para la gestión de la...RecruitingAnastomotic Complication | Anastomotic Leak Small Intestine | Anastomotic Leak Large IntestineSpain
-
Amsterdam UMC, location VUmcActive, not recruitingIntraoperative Awareness | Anastomotic Leak Rectum | Anastomotic Leak Small Intestine | Anastomotic Leak Large IntestineBelgium, Netherlands
-
National Research Oncology and Transplantology...RecruitingAnastomotic Leak Rectum | Anastomotic Leak Large IntestineKazakhstan
-
Sir Ganga Ram HospitalCompletedAnastomotic Leak Rectum | Anastomotic Leak Large Intestine | Colo-rectal SurgeryIndia
-
University Hospital, GhentWithdrawnAnastomotic Leak Esophagus
-
University Hospital TuebingenCompletedAnastomotic Leak EsophagusGermany
-
Hospital Universitari de BellvitgeCompletedEsophageal Anastomotic LeakSpain
-
VivostatEuropean Commission; Raffeiner GmbH; AF Schimetta GMbH; Rivolution GmbHRecruitingAnastomotic Leak RectumBelgium, Germany, Spain, Austria, Denmark, Italy, Serbia
-
Kepler University HospitalCompleted
Clinical Trials on No intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
Wright State UniversityCompleted