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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Aortic Aneurysm; Aortic Dissection; Morality
• Intervention / Treatment: Procedure: Lung surgery; Procedure: Open aortic surgery; Procedure: TEVAR; Procedure: EVAR

• Study Type: Observational
• Enrollment (Anticipated): 2224

Contacts and Locations

• Study Contact: Name: Sirilak Suksompong, MD; Phone Number: 66891534806; Email: sirilak.suk@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Anesthesiology Department Siriraj Hospital
      • Contact: Sirilak Suksompong, M.D.; Phone Number: 66891534806; Email: sirilak.suk@mahidol.ac.th
      • Contact: Sirintip Swangwong, M.D.; Phone Number: 66874535300; Email: peach.in.town@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent one of these types of surgery 1) thoracic surgery, 2) open thoracic aortic surgery, 3) TEVAR and 4) EVAR

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung surgery; Patients underwent lung surgery.	Procedure: Lung surgery; Patients underwent lung surgery including wedge resection, lobectomy, segmentectomy, and pneumonectomy.
Open aortic suregry; Patients underwent open aortic surgery.	Procedure: Open aortic surgery; Patients underwent open thoracic surgery or thoracoabdominal aortic surgery.
Thoracic endovascular aortic repair (TEVAR); Patients underwent TEVAR.	Procedure: TEVAR; Patients underwent TEVAR.
Endovascular aneurysm repair (EVAR); Patients underwent EVAR.	Procedure: EVAR; Patients underwent EVAR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of mortality and major complications after lung surgery	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	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.	30 days
Incidence of mortality and major complications after TEVAR	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	30 days
Incidence of mortality and major complications after EVAR	The mortality and major complications (CVS, CNS, RS and others) will be recorded.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of mortality and major complications after lung surgery	To identify risk factors eg. smoking, type of surgery, age, etc.	30 days
Risk factors of mortality and major complications after open aortic surgery	To identify risk factors eg. smoking, type of surgery, age, etc.	30 days
Risk factors of mortality and major complications after TEVAR	To identify risk factors eg. smoking, diagnosis, age, etc.	30 days
Risk factors of mortality and major complications after EVAR	To identify risk factors eg. smoking, age, etc.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	The patients with postoperative delirium required treatment will be described.	30 days
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
Risk factors of postoperative stroke.	To identify risk factors eg. smoking, type of surgery, age, etc.	30 days

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Mortality; Lung surgery; Endovascular aneurysm repair; Major complications; Open aortic surgery; Thoracic endovascular aortic repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm
• Other Study ID Numbers: 798/2564(IRB3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No