NCT05073991

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 23, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

October 2, 2021

Last Update Submit

October 23, 2021

Conditions

MoralityLung CancerAortic AneurysmAortic Dissection

Keywords

MortalityMajor complicationsLung surgeryOpen aortic surgeryThoracic endovascular aortic repairEndovascular aneurysm repair

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Risk factors of mortality and major complications after lung surgery

    30 days

  • Risk factors of mortality and major complications after open aortic surgery

    30 days

  • Risk factors of mortality and major complications after TEVAR

    30 days

  • Risk factors of mortality and major complications after EVAR

    30 days

Other Outcomes (3)

  • Incidence of postoperative delirium

    30 days

  • Incidence of low muscle mass

    7 days

  • Risk factors of postoperative stroke.

    30 days

Study Arms (4)

Lung surgery

Patients underwent lung surgery.

Procedure: Lung surgery

Open aortic suregry

Patients underwent open aortic surgery.

Procedure: Open aortic surgery

Thoracic endovascular aortic repair (TEVAR)

Patients underwent TEVAR.

Procedure: TEVAR

Endovascular aneurysm repair (EVAR)

Patients underwent EVAR.

Procedure: EVAR

Interventions

Lung surgeryPROCEDURE

Patients underwent lung surgery including wedge resection, lobectomy, segmentectomy, and pneumonectomy.

Lung surgery
Open aortic surgeryPROCEDURE

Patients underwent open thoracic surgery or thoracoabdominal aortic surgery.

Open aortic suregry
TEVARPROCEDURE

Patients underwent TEVAR.

Thoracic endovascular aortic repair (TEVAR)
EVARPROCEDURE

Patients underwent EVAR.

Endovascular aneurysm repair (EVAR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients underwent
  • thoracic surgery
  • open thoracic aortic surgery
  • TEVAR
  • EVAR

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsAortic AneurysmAortic Dissection

Interventions

Pulmonary Surgical ProceduresEndovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Sirilak Suksompong, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirilak Suksompong, MD

CONTACT

66891534806sirilak.suk@mahidol.ac.th

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 12, 2021

Study Start

October 23, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)