Thoracic Surgery, Video-Assisted Clinical Trial
Official title:
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.
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).
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