Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection

Thoracic Surgery Clinical Trial

Official title:

A Prospective Observational Study to Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827328
• Other study ID #: COVID-DS
• Status: Completed
• Start date: January 29, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.

2. Participants of any gender between the ages of 18 and 85 are eligible.

3. Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.

Exclusion Criteria:

1. Patients who have previously undergone lung surgery;

2. Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;

3. Patients who did not receive Chest computed tomography (CT) at admission or within 7 days before surgery, or whose Chest CT at admission suggests pneumonia or current infection with SARS-CoV-2 (confirmed by routine laboratory tests as positive nucleic acid in admission or on the day of surgery);

4. The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;

5. Local unresectable lesions or distant metastases are found intraoperatively.

Related Conditions & MeSH terms

• Thoracic Diseases
• Thoracic Surgery

Intervention

Other:
• Observation
Observe the 30-day mortality and 30-day morbidity.

Locations

Country	Name	City	State
China	Anhui Chest Hospital	Shanghai
China	Anqing Municipal Hospital	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	The First Affiliated Hospital of Anhui Medical University	Shanghai
China	Wuhan University Renmin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of perioperative mortality	30-day mortality after surgery	30 days after surgery
Secondary	The incidence of perioperative complications	30-day morbidity after surgery	30 days after surgery