Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,000
- 主要终点
- to identify factors associated to short lenght of stay after VATS lobectomy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the Italian VATS Group Database between January 2014 and January 2020
排除标准
- •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.
结局指标
主要结局
to identify factors associated to short lenght of stay after VATS lobectomy
时间窗: 2014-2020
to identify factors associated to short lenght of stay after VATS lobectomy
次要结局
- to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy(2014-2020)
研究者
Pio Maniscalco
Medical Doctor, Thoracic Surgeon
University Hospital of Ferrara
