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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05684549

Collaborator

(none)

2,000

Enrollment

Location

11.6

Anticipated Duration (Months)

172

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Corona Virus Infection	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Aug 11, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
stage I/II lung cancer patients Patients with stage I/II lung cancer will receive radical surgery.	Other: No intervention Observational study, no intervention

Arm

Intervention/Treatment

stage I/II lung cancer patients

Patients with stage I/II lung cancer will receive radical surgery.

Other: No intervention

Observational study, no intervention

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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