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

Sponsor
Lung Center of the Philippines (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513248
Collaborator
(none)
16
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: anatomic lung resection

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 Design

Study Type:
Observational
Anticipated Enrollment :
16 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019 (COVID-19): a Two-Year Retrospective Case Series
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Mortality [perioperative period (up to 30 days after anatomic lung resection)]

    cause of death should be a perioperative complication

  2. Major complication [perioperative period (up to 30 days after anatomic lung resection)]

    includes acute kidney injury, acute myocardial infarction, acute respiratory distress syndrome (ARDS), acute respiratory failure, atelectasis requiring intervention, bronchopleural fistula, empyema thoracis, hemothorax, pneumonia, stroke and venous thromboembolism

  3. Minor complications [perioperative period (within 30 days after anatomic lung resection)]

    includes atrial fibrillation, pneumothorax and prolonged air leak

  4. length of postoperative hospital stay [perioperative period (up to 30 days after anatomic lung resection)]

    time duration from surgery to discharge order

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lung Center of the Philippines

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alexander H. Tuliao, Dr., Lung Center of the Philippines
ClinicalTrials.gov Identifier:
NCT05513248
Other Study ID Numbers:
  • LCP-SF-013-2022
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022