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

NCT05827328 | Completed

• 1 other identifier: COVID-DS
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Thoracic Diseases; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of perioperative mortality

  30-day mortality after surgery

  30 days after surgery

Secondary Outcomes (1)

• The incidence of perioperative complications

  30 days after surgery

Study Arms (1)

Patients eligible for lung surgery or mediastinal surgery

Patients with or without SARS-CoV-2 infection eligible for lung surgery or mediastinal surgery

Other: Observation

Interventions

Observation OTHER

Observe the 30-day mortality and 30-day morbidity.

Patients eligible for lung surgery or mediastinal surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who undergo thoracic surgery for the clinical diagnosis of lung cancer or mediastinal tumors with or without SARS-CoV-2 infection.

You may qualify if:

• The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.
• Participants of any gender between the ages of 18 and 85 are eligible.
• Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.

You may not qualify if:

• Patients who have previously undergone lung surgery;
• Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;
• 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);
• The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;
• Local unresectable lesions or distant metastases are found intraoperatively.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (6)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

Anhui Chest Hospital

Shanghai, China

Location

Anqing Municipal Hospital

Shanghai, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

The First Affiliated Hospital of Anhui Medical University

Shanghai, China

Location

Wuhan University Renmin Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Thoracic Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Peng Zhang

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: April 25, 2023
• Study Start: January 29, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)