Clinical trial NCT05513248: Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019
Official title: Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019 (COVID-19): a Two-Year Retrospective Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lung Cancer
Lung TB
Hemoptysis
Lead sponsor: Lung Center of the Philippines
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who recovered from COVID-19, and who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality rate
timeFrame: perioperative period (up to 30 days after anatomic lung resection)
measure: Major complication rate
timeFrame: perioperative period (up to 30 days after anatomic lung resection)
measure: Minor complication rate
timeFrame: perioperative period (within 30 days after anatomic lung resection)
measure: Length of postoperative hospital stay
timeFrame: perioperative period (up to 30 days after anatomic lung resection)
Secondary outcomes:
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines
state: Metro Manila
Study officials:
affiliation: Lung Center of the Philippines
name: Alexander H Tuliao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.