NCT05684549Active, not recruitingNot Applicable
Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- postoperative morbidity
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
- postoperative hospital stay(postoperative in-hospital stay up to 30 days)
- operation time(At operation day)
- 30-day mortality(postoperative in-hospital stay up to 30 days)
- R0 rate(postoperative in-hospital stay up to 30 days)
- blood loss(At operation day)
- quality of life(postoperative in-hospital stay up to 30 days)
Investigators
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital
Study Sites (1)
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