Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche All'Interno Del Registro Vats Group (VATS)

August 10, 2020 updated by: Pio Maniscalco, University Hospital of Ferrara

Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche

Background VATS lobectomy centers face pressure to reduce hospitalization to contain costs, and some centers have sought to develop "fast-track" protocols. There are limited data to identify which patients would be appropriate for fast-tracking.

Objective The first objective was to identify factors associated to short lenght of stay after VATS lobectomy. The second objective was to verify the influence of these variables in uncomplicated VATS lobectomy.

Methods We reviewed all thoracoscopic lobectomies for cancer operations reported to the Italian VATS Group between January 2014 and January 2020. Patient and procedural characteristics, length of stay and 30-day morbidity and mortality were reviewed. Patients were divided into two subgroups depending on their reaching the targeted length of stay (≤ or > 4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤ 4 days was assessed using a stepwise multivariate logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data source The Italian VATS Group Database is a validated, risk-adjusted, prospective, outcomes-based program with 50 participating hospitals in Italy. The VATS Group Database collects data on different variables on a standardized data form: patient demographics informations, surgical interventions, medical history, cancer staging and outcome. Patients' outcomes are reviewed and records are updated the first time at 30 days after surgery, then at 180 days. Next update is recorded at 6 months from surgery and every 6 months for the first 2 years of follow-up, and annually thereafter. The VATS Group Database implements rigorous quality assurance and safety procedures to maintain a high level of accuracy and security of data.

The study has been approved by hospital ethics committee. The current analysis was reviewed and approved for scientific merit and feasibility by the VATS Group Scientific Committee and presented at the annual VATS Group meeting.

Patient population and study design Study population consisted of patients who received intended VATS lobectomy as the primary procedure for NSCLC at VATS Group participating centres and included in the VATS Group database between January 2014 and January 2020. We excluded all patients with incomplete clinical, intraoperative and postoperative data. Data entered from centers sporadically (less than 10 cases per year) were also excluded.

In order to analyse the factors related to lenght of stay, the study design provides a comparison between two groups of patients: the first group, identified as "LOS ≤ 4" including all patient disharged within 4 days after surgery, while the second group, called "LOS > 4" including all cases discharged after the fourth postoperative day.

Covariates We compared selected clinical variables to analyse the presence of a possible association with lenght of stay: data were divided into preoperative, intraoperative and postoperative.

Furthermore, three groups were made according to the number of cases entered by the different centers and considered as a possible influential variable: group A (less than 50 cases), group B (number of cases between 51 and 100) and group C (above 100 patients).

Statistical Analysis Patient baseline demographic and comorbidity variables were analyzed using frequencies and proportions for categorical variables and means, standard deviations (SDs), medians and interquartile ranges (IQR) for continuous variables.

The comparisons between groups (LOS ≤ 4 vs LOS > 4) categories were made by the following tests: Student t-test for continuous variables with approximately normal distribution, non-parametric Wilcoxon Mann Whitney test for other numerical variables and for categorical variables Pearson's chi-square test or Fisher's exact test in the case of low-volume categories were adopted.

To investigate the factors independently associated with the hospital stay outcome we used simple logistic regression models with the variables of interest, and a simplified multiple model with a stepwise backward procedure to obtain a more parsimonious model that contained only the significant factors. Covariates of interest were patients' demographics, co- morbidities, hospital lobectomy volume , operative features, pain relief techniques, type of surcial approach. A significance level of 0.2 was required to enter the model and a level of 0.05 was required to remain in the model. Adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) were presented. All P-values are two sided with statistical significance evaluated at the 0.05 α level. All tests were performed with Stata 13.0 statistical software (Stata Corp, College Station, TX).

Study Type

Observational

Enrollment (Actual)

10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were divided into two subgroups depending on their reaching the targeted length of stay (≤ or > 4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤ 4 days was assessed using a stepwise multivariate logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases.

Description

Inclusion Criteria:

  • Patients of the Italian VATS Group Database between January 2014 and January 2020

Exclusion Criteria:

  • Patients not included in the Italian VATS Group Database;
  • all patients with incomplete clinical, intraoperative and postoperative data and data entered from centers sporadically (less than 10 cases per year) were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vats Group
patients underwent planned VATS lobectomy for NSCLC from the Italian VATS Group Database (a validated, risk-adjusted, prospective, outcomes-based program with 50 participating hospitals in Italy) were included in the analysis.
Procedure: VATS lobectomy
VATS lobectomy allows surgeons to carry out exactly the same operation within the chest that is performed by thoracotomy, but it is done through 3-4 small incisions without rib spreading rather than the large incision with rib spreading that a thoracotomy entails. The surgeon gains his view inside the chest from a small video camera inserted through one of the small incisions, and the procedure is carried out with long instruments passed through the other small incisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to identify factors associated to short lenght of stay after VATS lobectomy
Time Frame: 2014-2020
to identify factors associated to short lenght of stay after VATS lobectomy
2014-2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy
Time Frame: 2014-2020
to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy
2014-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Study Director: GIORGIO CAVALLESCO, Professor, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EM352-2020_AOUFe/171173_EM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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