Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019

November 8, 2022 updated by: Alexander H. Tuliao, Lung Center of the Philippines

Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019 (COVID-19): a Two-Year Retrospective Case Series

This study will determine the outcomes of anatomic lung resections in patients who recovered from coronavirus disease 2019 (COVID-19) disease by describing the morbidity and mortality as well as the length of postoperative hospital stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted at the Lung Center of the Philippines. The study design is a retrospective case series implemented via chart review. Online and written patient records will be reviewed to determine the baseline patient characteristics and the preoperative outcomes. Patients who recovered from COVID-19 will be selected from those who underwent anatomic lung resection from June 1, 2020 to May 31, 2022. This study will be done in accordance with the Helsinky Declaration and Good Clinical Practice Guidelines, and will be subject for approval of the institutional Ethics and Technical Review Boards. Descriptive statistics will be used to describe patient characteristics and perioperative outcomes.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Metro Manila
      • Quezon City, Metro Manila, Philippines, 1100
        • Lung Center of the Philippines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who recovered from COVID-19, and who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy)

Description

Inclusion Criteria:

  • underwent anatomic lung resection
  • previous COVID-19 infection documented by nasopharyngeal swab RT-PCR or GeneXpert
  • with negative nasopharyngeal swab RT-PCR or GeneXpert prior to lung resection

Exclusion Criteria:

  • with incomplete patient records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients who recovered from COVID-19
patients with previous COVID-19 infection who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy)
Procedure: anatomic lung resection
includes minimally invasive or open lung segmentectomy, lobectomy, bilobectomy and pneumonectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: perioperative period (up to 30 days after anatomic lung resection)
proportion of patients who died due to perioperative complications
perioperative period (up to 30 days after anatomic lung resection)
Major complication rate
Time Frame: perioperative period (up to 30 days after anatomic lung resection)
proportion of patients who develop acute kidney injury, acute myocardial infarction, acute respiratory distress syndrome (ARDS), acute respiratory failure, atelectasis requiring intervention, bronchopleural fistula, empyema thoracis, hemothorax, pneumonia, stroke or venous thromboembolism
perioperative period (up to 30 days after anatomic lung resection)
Minor complication rate
Time Frame: perioperative period (within 30 days after anatomic lung resection)
proportion of patients who develop atrial fibrillation, pneumothorax or prolonged air leak
perioperative period (within 30 days after anatomic lung resection)
Length of postoperative hospital stay
Time Frame: perioperative period (up to 30 days after anatomic lung resection)
time duration from surgery to discharge order
perioperative period (up to 30 days after anatomic lung resection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lung Center of the Philippines

Investigators

  • Principal Investigator: Alexander H Tuliao, MD, Lung Center of the Philippines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCP-SF-013-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient baseline characteristics and outcomes

IPD Sharing Time Frame

5 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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