Status of Management of Surgery in Beijing During COVID-19

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04401124
• Other study ID #: BFH-SurgeryCovid
• Status: Not yet recruiting
• Start date: May 25, 2020
• Est. completion date: June 7, 2020

Study information

• Verified date: May 2020
• Source: Beijing Friendship Hospital
• Contact: Kai Pang, M.D.
• Phone: 18811792819
• Email: pang_kai[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 7, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Digestive System Diseases
• Gastric Cancer
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Cancer Hospital, Beijing Chao Yang Hospital, Beijing Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Shougang Hospital, Peking University Third Hospital, Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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