PACAGE: Prediction of Abdominal Complications After GastroEnterological Surgery

• Sponsor: Peking University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03828266
• Collaborator: (none)
• Enrollment: 4,000
• Locations: 19
• Anticipated Duration (Months): 24
• Patients Per Site: 210.5
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication; Anastomotic Leak; Gastrointestinal Cancer	Other: No intervention

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Abdominal Infection rate after gastrectomy. [From surgery until discharge, up to 90 days.]

   Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.

2. Abdominal Infection rate after colorectal surgery. [From surgery until discharge, up to 90 days.]

   Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.

Secondary Outcome Measures

1. Classification of Abdominal Infection after Surgery [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.

2. Diagnosis time of Abdominal Complication [From surgery until discharge, up to 90 days.]

   1-3 days after surgery; 4-7 days after surgery; >1wk after surgery

3. Outcome of Abdominal Infection Treatment [From surgery until discharge, up to 90 days.]

   Cured before discharge, not cured before discharge, death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Planned gastrointestinal surgery.

• Inform consent received.

Exclusion Criteria:

• Endoscopic surgery.

• Inform consent denied.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Beijing	Beijing	China	100142
2	Fujian Medical University Union Hospital	Fuzhou	Fujian	China
3	Xiamen University First Hospital	Xiamen	Fujian	China
4	Guangdong People's Hospital	Guangzhou	Guangdong	China
5	The First Affilliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
6	South Hospital	Guanzhou	Guangdong	China
7	Nanchang University First Hospital	Nanchang	Jiangxi	China
8	Jilin University Second Hospital	Changchun	Jilin	China
9	Dalian Medical University First Hospital	Dalian	Liaoning	China
10	Qinghai University Affiliated Hospital	Xining	Qinghai	China
11	Shandong Provincial Hospital	Jinan	Shandong	China
12	Qingdao University Affiliated Hospital	Qingdao	Shandong	China
13	Fudan University Cancer Hospital	Shanghai	Shanghai	China
14	Huashan Hospital	Shanghai	Shanghai	China
15	Ruijin Hospital	Shanghai	Shanghai	China
16	Zhongshan Hospital	Shanghai	Shanghai	China
17	Xi'an Jiao Tong University First Hospital	Xi'an	Shanxi	China
18	Hangzhou First Hospital	Hangzhou	Zhejiang	China
19	Run Run Shaw Hospital	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Peking University

Investigators

• Principal Investigator: Ziyu Li, MD PhD, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziyu Li, MD, Prof. Dr., Peking University
• ClinicalTrials.gov Identifier: NCT03828266
• Other Study ID Numbers: 2018YJZ56
• First Posted: Feb 4, 2019
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Anastomotic Leak

Study Results

No Results Posted as of Feb 4, 2019