Assessment of the 90-day Mortality Risk Score After VATS Lobectomy

NCT ID: NCT04799509

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-11-27

Brief Summary

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A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity \<60% (1 point) and operative time \>150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

Detailed Description

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From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.

Conditions

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Lung Cancer Surgery--Complications Morality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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VATS lobectomy

VATS lobectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Patients undergoing VATS lobectomy for non-small cell lung cancer

Exclusion Criteria

* Incomplete data for risk score calculation
* Tumor size \>5 cm
* Follow-up \<3 months
* Patients undergoing neoadjuvant treatment
* Patients undergoing extended resection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Maria Cattoni

Principal Investigator - Clinician at Center for Thoracic Surgery - School of Medicine and Surgery - University of Insubria - Varese

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Imperatori, MD

Role: STUDY_DIRECTOR

Università degli Studi dell'Insubria

References

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Brunelli A, Dinesh P, Woodcock-Shaw J, Littlechild D, Pompili C. Ninety-Day Mortality After Video-Assisted Thoracoscopic Lobectomy: Incidence and Risk Factors. Ann Thorac Surg. 2017 Sep;104(3):1020-1026. doi: 10.1016/j.athoracsur.2017.02.083. Epub 2017 Jun 1.

Reference Type BACKGROUND
PMID: 28577845 (View on PubMed)

Other Identifiers

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VALIDATION

Identifier Type: -

Identifier Source: org_study_id

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