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

Surgery Clinical Trial

— COVIDLungSurg  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684549
• Other study ID #: RTS-017
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Zhenyi Niu
• Phone: +8618349281387
• Email: 18622977[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Infections
• Lung Neoplasms
• Surgery
• Virus Diseases

Intervention

Other:
• No intervention
Observational study, no intervention

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative morbidity	rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.	postoperative in-hospital stay up to 30 days
Secondary	postoperative hospital stay	length of postoperative hospitalization	postoperative in-hospital stay up to 30 days
Secondary	operation time	duration of operation	At operation day
Secondary	R0 rate	R0 resection rate	postoperative in-hospital stay up to 30 days
Secondary	blood loss	blood loss in the operation	At operation day
Secondary	30-day mortality	30-day mortality after surgery	postoperative in-hospital stay up to 30 days
Secondary	quality of life	postoperative quality of life	postoperative in-hospital stay up to 30 days