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NCT05685914 Clinical Trial

Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.

COVID-19 Clinical Trial

Official title:
Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05685914
Other study ID # qiwu
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date August 31, 2023

Study information
Verified date January 2023
Source Peking University Cancer Hospital & Institute
Contact Lin Chang
Phone +86 01088196613
Email changlin0730@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date August 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery. Exclusion Criteria: - If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopic surgery
Emergency or elective surgery

Locations
Country Name City State
China Peking University Cancer Hospital & Institute Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 30-day mortality Death up to 30-days post surgery 30 days
Secondary postoperative complications Determine postoperative complications one month after surgery. 30 days
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