Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer

Active, not recruiting

• Conditions: Surgery; Corona Virus Infection
• Interventions: Other: No intervention

• Registration Number: NCT05684549
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-13
• Primary Completion: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stage I/II lung cancer patients	No intervention	Patients with stage I/II lung cancer will receive radical surgery.

Primary Outcome Measures

Name	Time	Method
postoperative morbidity	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.

Secondary Outcome Measures

Name	Time	Method
postoperative hospital stay	postoperative in-hospital stay up to 30 days	length of postoperative hospitalization
operation time	At operation day	duration of operation
30-day mortality	postoperative in-hospital stay up to 30 days	30-day mortality after surgery
R0 rate	postoperative in-hospital stay up to 30 days	R0 resection rate
blood loss	At operation day	blood loss in the operation
quality of life	postoperative in-hospital stay up to 30 days	postoperative quality of life

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China