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

NCT05513248 | Completed

• 1 other identifier: LCP-SF-013-2022
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Lung Cancer; Lung TB; Hemoptysis

Outcome Measures

Primary Outcomes (4)

• Mortality rate

  proportion of patients who died due to perioperative complications

  perioperative period (up to 30 days after anatomic lung resection)

• Major complication rate

  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

  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 duration from surgery to discharge order

  perioperative period (up to 30 days after anatomic lung resection)

Study Arms (1)

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

Interventions

anatomic lung resection PROCEDURE

includes minimally invasive or open lung segmentectomy, lobectomy, bilobectomy and pneumonectomy

patients who recovered from COVID-19

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• with incomplete patient records

Sponsors & Collaborators

• Lung Center of the Philippines: lead

Study Sites (1)

Lung Center of the Philippines

Quezon City, National Capital Region, 1100, Philippines

Location

Related Publications (5)

• Sakai T, Azuma Y, Aoki K, Wakayama M, Miyoshi S, Kishi K, Tateda K, Homma S, Iyoda A. Elective lung resection after treatment for COVID-19 pneumonia. Gen Thorac Cardiovasc Surg. 2021 Jul;69(7):1159-1162. doi: 10.1007/s11748-021-01630-4. Epub 2021 Apr 3.

  PMID: 33811611 BACKGROUND

• Testori A, Perroni G, Voulaz E, Crepaldi A, Alloisio M. Pulmonary Lobectomy After COVID-19. Ann Thorac Surg. 2021 Mar;111(3):e181-e182. doi: 10.1016/j.athoracsur.2020.08.004. Epub 2020 Sep 25.

  PMID: 32987024 BACKGROUND

• Nefedov A, Mortada M, Novitskaya T, Patsyuk A, Kozak A, Yablonskii P. Lobectomy with pathological examination in lung cancer patients who recovered from COVID-19. Gen Thorac Cardiovasc Surg. 2021 Aug;69(8):1258-1260. doi: 10.1007/s11748-021-01632-2. Epub 2021 Apr 9.

  PMID: 33837476 BACKGROUND

• Diaz A, Bujnowski D, McMullen P, Lysandrou M, Ananthanarayanan V, Husain AN, Freeman R, Vigneswaran WT, Ferguson MK, Donington JS, Madariaga MLL, Abdelsattar ZM. Pulmonary Parenchymal Changes in COVID-19 Survivors. Ann Thorac Surg. 2022 Jul;114(1):301-310. doi: 10.1016/j.athoracsur.2021.06.076. Epub 2021 Jul 31.

  PMID: 34343471 BACKGROUND

• COVIDSurg Collaborative; GlobalSurg Collaborative. Timing of surgery following SARS-CoV-2 infection: an international prospective cohort study. Anaesthesia. 2021 Jun;76(6):748-758. doi: 10.1111/anae.15458. Epub 2021 Mar 9.

  PMID: 33690889 BACKGROUND

MeSH Terms

Conditions

COVID-19; Lung Neoplasms; Tuberculosis, Pulmonary; Hemoptysis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Alexander H Tuliao, MD

  Lung Center of the Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer III

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: October 10, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 1, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years

Locations

PH (1)