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

Completed

• Conditions: Thoracic Diseases; Thoracic Surgery
• Interventions: Other: Observation

• Registration Number: NCT05827328
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-29
• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-16
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients eligible for lung surgery or mediastinal surgery	Observation	Patients with or without SARS-CoV-2 infection eligible for lung surgery or mediastinal surgery

Primary Outcome Measures

Name	Time	Method
The incidence of perioperative mortality	30 days after surgery	30-day mortality after surgery

Secondary Outcome Measures

Name	Time	Method
The incidence of perioperative complications	30 days after surgery	30-day morbidity after surgery

Trial Locations

Locations (6)

Anqing Municipal Hospital; 🇨🇳 Shanghai, China

Anhui Chest Hospital; 🇨🇳 Shanghai, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

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

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Shanghai, China

Wuhan University Renmin Hospital; 🇨🇳 Shanghai, China