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

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05073991
Collaborator
(none)
2,224
Enrollment
25
Anticipated Duration (Months)

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 DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/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

  1. Incidence of mortality and major complications after lung surgery [30 days]

    The mortality and major complications (CVS, CNS, RS and others) will be recorded.

  2. 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.

  3. Incidence of mortality and major complications after TEVAR [30 days]

    The mortality and major complications (CVS, CNS, RS and others) will be recorded.

  4. 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

  1. Risk factors of mortality and major complications after lung surgery [30 days]

    To identify risk factors eg. smoking, type of surgery, age, etc.

  2. Risk factors of mortality and major complications after open aortic surgery [30 days]

    To identify risk factors eg. smoking, type of surgery, age, etc.

  3. Risk factors of mortality and major complications after TEVAR [30 days]

    To identify risk factors eg. smoking, diagnosis, age, etc.

  4. Risk factors of mortality and major complications after EVAR [30 days]

    To identify risk factors eg. smoking, age, etc.

Other Outcome Measures

  1. Incidence of postoperative delirium [30 days]

    The patients with postoperative delirium required treatment will be described.

  2. 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

  3. Risk factors of postoperative stroke. [30 days]

    To identify risk factors eg. smoking, type of surgery, age, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Sirilak Suksompong, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT05073991
Other Study ID Numbers:
  • 798/2564(IRB3)
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mahidol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021