Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073991
• Other study ID #: 798/2564(IRB3)
• Status: Recruiting
• Start date: October 23, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: Mahidol University
• Contact: Sirilak Suksompong, MD
• Phone: 66891534806
• Email: sirilak.suk[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Also the study of the risk factors of mortality and major complications will help to improve the patients' outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2224
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients underwent

• thoracic surgery
• open thoracic aortic surgery
• TEVAR
• EVAR

Exclusion Criteria:

• Emergency lung surgery
• Conversion from TEVAR to open thoracic surgery
• Conversion from EVAR to open aortic surgery

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Dissection
• Lung Cancer
• Morality

Intervention

Procedure:
• Lung surgery
Patients underwent lung surgery including wedge resection, lobectomy, segmentectomy, and pneumonectomy.
• Open aortic surgery
Patients underwent open thoracic surgery or thoracoabdominal aortic surgery.
• TEVAR
Patients underwent TEVAR.
• EVAR
Patients underwent EVAR.

Locations

Country	Name	City	State
Thailand	Anesthesiology Department Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of postoperative delirium	The patients with postoperative delirium required treatment will be described.	30 days
Other	Incidence of low muscle mass	Psoas muscle index will be used for the diagnosis of low muscle mass. Psoas muscle index = both psoas muscle area at L3 (from CT scan) divided by body surface area.; Cut-off values of sarcopenia; Male 68.5 cm2/m2; Female 52.5 cm2/m2	7 days
Other	Risk factors of postoperative stroke.	To identify risk factors eg. smoking, type of surgery, age, etc.	30 days
Primary	Incidence of mortality and major complications after lung surgery	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	30 days
Primary	Incidence of mortality and major complications after open aortic surgery	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	30 days
Primary	Incidence of mortality and major complications after TEVAR	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	30 days
Primary	Incidence of mortality and major complications after EVAR	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	30 days
Secondary	Risk factors of mortality and major complications after lung surgery	To identify risk factors eg. smoking, type of surgery, age, etc.	30 days
Secondary	Risk factors of mortality and major complications after open aortic surgery	To identify risk factors eg. smoking, type of surgery, age, etc.	30 days
Secondary	Risk factors of mortality and major complications after TEVAR	To identify risk factors eg. smoking, diagnosis, age, etc.	30 days
Secondary	Risk factors of mortality and major complications after EVAR	To identify risk factors eg. smoking, age, etc.	30 days