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

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05073991

Collaborator

(none)

2,224

Enrollment

Location

26.3

Anticipated Duration (Months)

84.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Morality Lung Cancer Aortic Aneurysm Aortic Dissection	Procedure: Lung surgery Procedure: Open aortic surgery Procedure: TEVAR Procedure: EVAR

Study Design

Study Type:

Observational

Anticipated Enrollment :

2224 participants

Observational Model:

Family-Based

Time Perspective:

Retrospective

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

Actual Study Start Date :

Oct 23, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

Incidence of mortality and major complications after lung surgery [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 [30 days]
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Incidence of mortality and major complications after TEVAR [30 days]
The mortality and major complications (CVS, CNS, RS and others) will be recorded.
Incidence of mortality and major complications after EVAR [30 days]
The mortality and major complications (CVS, CNS, RS and others) will be recorded.

Secondary Outcome Measures

Risk factors of mortality and major complications after lung surgery [30 days]
To identify risk factors eg. smoking, type of surgery, age, etc.
Risk factors of mortality and major complications after open aortic surgery [30 days]
To identify risk factors eg. smoking, type of surgery, age, etc.
Risk factors of mortality and major complications after TEVAR [30 days]
To identify risk factors eg. smoking, diagnosis, age, etc.
Risk factors of mortality and major complications after EVAR [30 days]
To identify risk factors eg. smoking, age, etc.

Other Outcome Measures

Incidence of postoperative delirium [30 days]
The patients with postoperative delirium required treatment will be described.
Incidence of low muscle mass [7 days]
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
Risk factors of postoperative stroke. [30 days]
To identify risk factors eg. smoking, type of surgery, age, etc.