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OpenTrials
Completed

NCT Number: NCT04799509

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Morality Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Surgery--Complications Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VATS lobectomy

Procedure

VATS lobectomy

Primary outcomes

  1. 90-day postoperative mortality

    Time frame: 90 day post surgical procedure

    Alive/Death (cause of death)

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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