MoralityNCT05073991
Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
An observational study of Morality and Lung Cancer, run by Mahidol University at 1 site in Thailand.
Trial summary
Lung surgery, open aortic surgery, TEVAR, and EVAR are major operations that carry a higher incidence of perioperative mortality and complications compare to other surgery. The study of the incidence of mortality and complications will help the hospital to benchmark with the others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morality, Lung Cancer, Aortic Aneurysm
- What is being tested?
- Lung surgery, Open aortic surgery and TEVAR
- Type of treatment
- Surgery or procedure
- How many people
- 2,224 participants
- Where
- 1 siteThailand
- Study dates
- 23 Oct 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent one of these types of surgery 1) thoracic surgery, 2) open thoracic aortic surgery, 3) TEVAR and 4) EVAR
Who may be able to join
- Patients underwent
- thoracic surgery
- open thoracic aortic surgery
- TEVAR
- EVAR
Who cannot join
- Emergency lung surgery
- Conversion from TEVAR to open thoracic surgery
- Conversion from EVAR to open aortic surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Anesthesiology Department Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Sirilak Suksompong, M.D., 66891534806, sirilak.suk@mahidol.ac.th
Sirintip Swangwong, M.D., 66874535300, peach.in.town@gmail.com
About this study
Official title: Incidence of Perioperative Mortality and Major Complications in Patients Who Underwent Lung Surgery, Open Thoracic Aortic Repair, Thoracic Endovascular Aortic Repair (TEVAR), and Endovascular Aortic Repair (EVAR). A Retrospective Study
Lung surgery, open aortic surgery, TEVAR, and EVAR are major operations that carry a higher incidence of perioperative mortality and complications compare to other surgery. The study of the incidence of mortality and complications will help the hospital to benchmark with the others. Also the study of the risk factors of mortality and major complications will help to improve the patients' outcomes.
- Conditions
- Morality, Lung Cancer, Aortic Aneurysm, Aortic Dissection
- Being tested
- Lung surgery, Open aortic surgery, TEVAR, EVAR
- Keywords
- Mortality, Major complications, Lung surgery, Open aortic surgery, Thoracic endovascular aortic repair, Endovascular aneurysm repair
- Medical subject headings
- Lung Neoplasms, Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung surgeryProcedure or surgery
Patients underwent lung surgery including wedge resection, lobectomy, segmentectomy, and pneumonectomy.
Open aortic surgeryProcedure or surgery
Patients underwent open thoracic surgery or thoracoabdominal aortic surgery.
TEVARProcedure or surgery
Patients underwent TEVAR.
EVARProcedure or surgery
Patients underwent EVAR.
| Study group | Role | What they receive |
|---|---|---|
| Lung surgery | Patients underwent lung surgery. Receives: Procedure: Lung surgery | |
| Open aortic suregry | Patients underwent open aortic surgery. Receives: Procedure: Open aortic surgery | |
| Thoracic endovascular aortic repair (TEVAR) | Patients underwent TEVAR. Receives: Procedure: TEVAR | |
| Endovascular aneurysm repair (EVAR) | Patients underwent EVAR. Receives: Procedure: EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mortality and major complications after lung surgery
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Measured: 30 days
Incidence of mortality and major complications after open aortic surgery
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Measured: 30 days
Incidence of mortality and major complications after TEVAR
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Measured: 30 days
Incidence of mortality and major complications after EVAR
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Measured: 30 days
Secondary outcomes (4)
Risk factors of mortality and major complications after lung surgery
To identify risk factors eg. smoking, type of surgery, age, etc.
Measured: 30 days
Risk factors of mortality and major complications after open aortic surgery
To identify risk factors eg. smoking, type of surgery, age, etc.
Measured: 30 days
Risk factors of mortality and major complications after TEVAR
To identify risk factors eg. smoking, diagnosis, age, etc.
Measured: 30 days
Risk factors of mortality and major complications after EVAR
To identify risk factors eg. smoking, age, etc.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start23 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 2,224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073991
- Sponsor's protocol ID
- 798/2564(IRB3)
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Perioperative Mortality and Major Complications in Patients Who Underwent Lung Surgery, Open Thoracic Aortic Repair, Thoracic Endovascular Aortic Repair (TEVAR), and Endovascular Aortic Repair (EVAR). A Retrospective Study
- ClinicalTrials.gov ID
- NCT05073991
- Acronym / sponsor ID
- 798/2564(IRB3)
- Conditions
- Morality, Lung Cancer, Aortic Aneurysm, Aortic Dissection
- Keywords
- Mortality, Major complications, Lung surgery, Open aortic surgery, Thoracic endovascular aortic repair, Endovascular aneurysm repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,224 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Oct 2021 (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.
Lung surgery, open aortic surgery, TEVAR, and EVAR are major operations that carry a higher incidence of perioperative mortality and complications compare to other surgery. The study of the incidence of mortality and complications will help the hospital to benchmark with the others. Also the study of the risk factors of mortality and major complications will help to improve the patients' outcomes.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lung surgery | – | Procedure: Lung surgeryPatients underwent lung surgery. |
| Open aortic suregry | – | Procedure: Open aortic surgeryPatients underwent open aortic surgery. |
| Thoracic endovascular aortic repair (TEVAR) | – | Procedure: TEVARPatients underwent TEVAR. |
| Endovascular aneurysm repair (EVAR) | – | Procedure: EVARPatients underwent EVAR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent one of these types of surgery 1) thoracic surgery, 2) open thoracic aortic surgery, 3) TEVAR and 4) EVAR
Key inclusion criteria (5 listed)
- Patients underwent
- thoracic surgery
- open thoracic aortic surgery
- TEVAR
- EVAR
Key exclusion criteria (3 listed)
- Emergency lung surgery
- Conversion from TEVAR to open thoracic surgery
- Conversion from EVAR to open aortic surgery
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 |
|---|---|---|
| Lung surgeryPatients underwent lung surgery including wedge resection, lobectomy, segmentectomy, and pneumonectomy. | Procedure or surgery | Lung surgery |
| Open aortic surgeryPatients underwent open thoracic surgery or thoracoabdominal aortic surgery. | Procedure or surgery | Open aortic suregry |
| TEVARPatients underwent TEVAR. | Procedure or surgery | Thoracic endovascular aortic repair (TEVAR) |
| EVARPatients underwent EVAR. | Procedure or surgery | Endovascular aneurysm repair (EVAR) |
Primary outcome
Incidence of mortality and major complications after lung surgery
Time frame: 30 days
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Incidence of mortality and major complications after open aortic surgery
Time frame: 30 days
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Incidence of mortality and major complications after TEVAR
Time frame: 30 days
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Incidence of mortality and major complications after EVAR
Time frame: 30 days
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
4 secondary outcomes
Risk factors of mortality and major complications after lung surgery
Time frame: 30 days
Risk factors of mortality and major complications after open aortic surgery
Time frame: 30 days
Risk factors of mortality and major complications after TEVAR
Time frame: 30 days
Risk factors of mortality and major complications after EVAR
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Sirilak Suksompong, MD principal investigator
Mahidol University
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 Morality and Lung Cancer, run by Mahidol University at 1 site in Thailand.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Nov 2021. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirilak Suksompong, MD (66891534806, sirilak.suk@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mortality and major complications after lung surgery (time frame: 30 days). 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?
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 1 Nov 2021.