COVID-19NCT05513248
Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019
An observational study of COVID-19 and Lung Cancer, run by Lung Center of the Philippines at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Lung Cancer, Lung TB
- What is being tested?
- anatomic lung resection
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 sitePhilippines
- Study dates
- 10 Oct 2022to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who recovered from COVID-19, and who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy)
Who may be able to join
- 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
Who cannot join
- with incomplete patient records
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Lung Center of the Philippines
Quezon City, National Capital Region, 1100
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Lung Cancer, Lung TB, Hemoptysis
- Being tested
- anatomic lung resection
- Medical subject headings
- COVID-19, Lung Neoplasms, Tuberculosis, Pulmonary, Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anatomic lung resectionProcedure or surgery
includes minimally invasive or open lung segmentectomy, lobectomy, bilobectomy and pneumonectomy
| Study group | Role | What they receive |
|---|---|---|
| patients who recovered from COVID-19 | patients with previous COVID-19 infection who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy) Receives: Procedure: anatomic lung resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
proportion of patients who died due to perioperative complications
Measured: 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
Measured: 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
Measured: perioperative period (within 30 days after anatomic lung resection)
Length of postoperative hospital stay
time duration from surgery to discharge order
Measured: perioperative period (up to 30 days after anatomic lung resection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start10 Oct 2022
- Primary completion31 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lung Center of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander H. Tuliao, Lung Center of the Philippines
- Investigators
- Alexander H Tuliao, MD, Principal investigator, Lung Center of the Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513248
- Sponsor's protocol ID
- LCP-SF-013-2022
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient baseline characteristics and outcomes
Publications
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.
PubMed 33811611Testori 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.
PubMed 32987024Nefedov 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.
PubMed 33837476Diaz 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.
PubMed 34343471COVIDSurg Collaborative and 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.
PubMed 33690889
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes of Anatomic Lung Resections in Patients Who Recovered From Coronavirus Disease 2019 (COVID-19): a Two-Year Retrospective Case Series
- ClinicalTrials.gov ID
- NCT05513248
- Acronym / sponsor ID
- LCP-SF-013-2022
- Conditions
- COVID-19, Lung Cancer, Lung TB, Hemoptysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Lung Center of the PhilippinesUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who recovered from COVID-19 | – | Procedure: anatomic lung resectionpatients with previous COVID-19 infection who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who recovered from COVID-19, and who underwent anatomic lung resection (segmentectomy, lobectomy, bilobectomy or pneumonectomy)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- with incomplete patient records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anatomic lung resectionincludes minimally invasive or open lung segmentectomy, lobectomy, bilobectomy and pneumonectomy | Procedure or surgery | patients who recovered from COVID-19 |
Primary outcome
Mortality rate
Time frame: perioperative period (up to 30 days after anatomic lung resection)
proportion of patients who died due to perioperative complications
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
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
Length of postoperative hospital stay
Time frame: perioperative period (up to 30 days after anatomic lung resection)
time duration from surgery to discharge order
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Background: PubMed 33811611Sakai 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.
- Background: PubMed 32987024Testori 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.
- Background: PubMed 33837476Nefedov 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.
- Background: PubMed 34343471Diaz 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.
- Background: PubMed 33690889COVIDSurg Collaborative and 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.
- Individual participant dataSharing planned: Yes. Patient baseline characteristics and outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander H Tuliao, MD principal investigator
Lung Center of the Philippines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Lung Cancer, run by Lung Center of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: perioperative period (up to 30 days after anatomic lung resection)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05513248, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.