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

NCT04511091 | Completed DMC

• 1 other identifier: EM352-2020_AOUFe/171173_EM1
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thoracic Surgery, Video-Assisted

Keywords

VATS; lobectomy; length-of-stay; hospitalization; fast-track; discharge

Outcome Measures

Primary Outcomes (1)

• to identify factors associated to short lenght of stay after VATS lobectomy

  to identify factors associated to short lenght of stay after VATS lobectomy

  2014-2020

Secondary Outcomes (1)

• to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy

  2014-2020

Study Arms (1)

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

Interventions

VATS lobectomy PROCEDURE

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.

Vats Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Related Publications (26)

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Study Officials

• GIORGIO CAVALLESCO, Professor

  Università degli Studi di Ferrara

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Thoracic Surgeon

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: January 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08