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

NCT ID: NCT05827328

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-29

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Thoracic Diseases Thoracic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients eligible for lung surgery or mediastinal surgery

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

Observation

Intervention Type OTHER

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

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Peng Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Zhang

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Shanghai Pulmonary Hospital

Shanghai, , China

Site Status

Anhui Chest Hospital

Shanghai, , China

Site Status

Anqing Municipal Hospital

Shanghai, , China

Site Status

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

The First Affiliated Hospital of Anhui Medical University

Shanghai, , China

Site Status

Wuhan University Renmin Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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COVID-DS

Identifier Type: -

Identifier Source: org_study_id

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