Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer

Ruijin Hospital1 site in 1 country2,000 target enrollmentJanuary 11, 2023

ConditionsSurgery Corona Virus Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgery
Sponsor: Ruijin Hospital
Enrollment: 2000
Locations: 1
Primary Endpoint: postoperative morbidity
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.

Registry

clinicaltrials.gov

Start Date

January 11, 2023

End Date

December 31, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Hecheng Li M.D., Ph.D

Professor

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

•Clinically diagnosed stage I and stage II lung cancer, who are about to receive wedge resection, segmental resection, sleeve resection, lobectomy, or pneumonectomy under general anaesthesia.
•Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent.
•ASA score: I-III;
•Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria

•Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
•Clinically diagnosed stage III and stage IV lung cancer or patients who received neoadjuvant treatment before surgery;
•Patients developed symptoms alike coronavirus infection but are not confirmed by viral RNA detection by quantitative RT-PCR or antigen testing kits.
•Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation

Outcomes

Primary Outcomes

postoperative morbidity

Time Frame: postoperative in-hospital stay up to 30 days

rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.