Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04511091
Study type Observational
Source University Hospital of Ferrara
Contact
Status Completed
Phase
Start date January 1, 2014
Completion date July 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT02952261 - Application of 3D Printing Technique in Small Pulmonary Nodule Localization N/A
Completed NCT05106283 - Comparison of Deep Serratus Anterior Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block N/A
Completed NCT05105282 - Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block N/A
Completed NCT05926817 - Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery N/A
Not yet recruiting NCT06061250 - Effect of Gum Chewing on Sore Throat After Double-lumen Tube Intubation N/A
Recruiting NCT04062045 - Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After VATS Procedures N/A
Recruiting NCT03666299 - Lidocaine Infusion for Postthoracotomy Pain Syndrome N/A
Completed NCT03860480 - Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery N/A
Completed NCT03296449 - Comparison Between CPAP and HFJV During One-lung Ventilation in VATS N/A
Completed NCT06118593 - Why in Hospital After Wedge Resection
Completed NCT03648008 - Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy Phase 4
Completed NCT05235815 - Ultrasound- Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block N/A
Completed NCT05121727 - Comparison of Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block N/A
Recruiting NCT05907525 - Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation N/A
Recruiting NCT05834569 - Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients Phase 4
Completed NCT03916120 - Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure
Recruiting NCT00425022 - VATS Lobectomy for Clinical Stage IB or II Lung Cancer Phase 2
Recruiting NCT05600569 - Registry of the Spanish Society of Thoracic Surgery
Not yet recruiting NCT06289790 - Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS) N/A
Completed NCT04665531 - Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery N/A