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Clinical Trials/NCT04799509
NCT04799509CompletedNot Applicable

Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort

Università degli Studi dell'Insubria0 sites2,209 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,209
Primary Endpoint
90-day postoperative mortality

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

90-day postoperative mortality

Time Frame: 90 day post surgical procedure

Alive/Death (cause of death)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Università degli Studi dell'Insubria
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Cattoni

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

Università degli Studi dell'Insubria

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