Status of Management of Surgery in Beijing During COVID-19

A Descriptive Study on the Proper Management of Gastrointestinal Surgeries During the COVID-19 Pandemic, With an Emphasis on the Alteration of Surgical Protocol and Workflow

This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Colorectal Cancer; Gastrointestinal Disease
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Kai Pang, M.D.; Phone Number: 18811792819 18811792819; Email: pang_kai@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at surgical ER, and patients in gastrointestinal wards

Description

Inclusion Criteria:

• All patients arriving at surgical emergency and all patients receiving gastrointestinal surgeries in participating centers from 2020.1.1~2020.3.31.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients treated at surgical emergency rooms	Other: no intervention; no intervention
patients receiving surgeries (both elected and emergency)	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment of fevers at arrival	proportion of patients presented with fever, proportion of patients refered to fever clinics, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)	1 day
treatment of post-operative fevers	proportion of patients on whom fever occured, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)	1 day
assorted surgical parameters	Duration of operation (≥180min/<180min); Intra-operative transfusion (Y/N); Surgical approach (Laparoscopy-involved/Open); Resection range (Non-radical/Radical); Lymph node dissection (Unknown/Not dissected/D1/D2 or above); Combined organ resection (Y/N); Post-operative complications (Y/N); Post-operative transfusion (Y/N); Post-operative hospital stay (≥7d/<7d)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitals' protection measures and extent of implementation	Out-patient of surgery (Open/Closed); Emergency of surgery (Open/Closed); Fever clinic (Open/Closed); Surgical ward (Open/Closed); Functional level of surgical ward (Receive emergency surgery patients only/Receive surgery patients only/Receive all kinds of patients); Isolation ward for suspected COVID-19 patients (With/Without); Bed number in each surgical ward room (1/2/≥3); Isolation area within surgical ward (With/Without); Usage of sub-pressure operation theaters (Routinely applied/Applied for suspected patients/Never applied); Protection level of surgeons in surgical ward (No specific protection/Regular medical masks/Any of N95 mask, eye/face shields, gowns); Protection level of surgeons in ER room (No specific protection/Regular medical masks/Any of N95 mask, eye shields, face shields, gowns)	1 month

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking University First Hospital; Peking University People's Hospital; Peking Union Medical College Hospital; Chinese PLA General Hospital; Peking University Third Hospital; Peking University Cancer Hospital & Institute; Xuanwu Hospital, Beijing; Peking University Shougang Hospital; Beijing Chao Yang Hospital; Beijing Hospital; China-Japan Friendship Hospital
• Investigators: Principal Investigator: Zhongtao Zhang, M.D., Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2020
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): June 7, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: BFH-SurgeryCovid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No