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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05513248
• Other study ID #: LCP-SF-013-2022
• Status: Completed
• Start date: October 10, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Lung Center of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Hemoptysis
• Lung Cancer
• Lung TB

Intervention

Procedure:
• anatomic lung resection
includes minimally invasive or open lung segmentectomy, lobectomy, bilobectomy and pneumonectomy

Locations

Country	Name	City	State
Philippines	Lung Center of the Philippines	Quezon City	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
Lung Center of the Philippines

Country where clinical trial is conducted

Philippines, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	proportion of patients who died due to perioperative complications	perioperative period (up to 30 days after anatomic lung resection)
Primary	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)
Primary	Minor complication rate	proportion of patients who develop atrial fibrillation, pneumothorax or prolonged air leak	perioperative period (within 30 days after anatomic lung resection)
Primary	Length of postoperative hospital stay	time duration from surgery to discharge order	perioperative period (up to 30 days after anatomic lung resection)