跳至主要内容
临床试验/NCT06389890
NCT06389890已完成不适用

Pancreatic Surgery - Optimal Caseload Thresholds and Predictive Accuracy

Richard Hunger0 个研究点目标入组 80,000 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80,000
主要终点
In-hospital mortality

研究概览

简要总结

The main objective of the study is to identify the optimal annual number of cases in a hospital with regard to minimising hospital mortality in pancreatic surgery. In particular, the prognostic value of such case numbers will be analysed.

详细描述

Main research questions:

  • Can specific intervention case numbers be identified that are suitable as thresholds for annual minimum volumes and are associated with significantly low hospital mortality?
  • Almost all previous studies on case number effects have only shown a descriptive association between the number of cases in a given year and the quality of outcomes in the same year. The aim of this study is to investigate whether the correlations described can be demonstrated when using the previous year's procedure volume as a predictor. The study seeks to answer whether the procedure caseload has predictive value, specifically the number of cases in one year and in-hospital mortality in the following year.

Background:

Numerous studies have demonstrated a correlation between the number of cases and the quality of outcomes for various surgical procedures. For instance, patients who underwent surgery in high-volume hospitals (HVH) had lower mortality rates, longer survival rates, lower complication rates, and lower reoperation rates than patients who underwent surgery in low-volume hospitals (LVH). To subdivide into HVHs and LVHs, either concrete case numbers or quartile or quintile limits with an equal number of operations or clinics per group wer used. The aim of the study is to objectively determine these limits using a spline-modeled caseload term, avoiding arbitrary decisions.

One limitation of the previous findings is that they may not be generalisable due to the use of a limited number of cases and outcome quality from the same year. However, it is important to note that the volume from the previous year is crucial in determining the predictive importance of caseload for future outcome quality. A recent study (in press) reported, that there are significant fluctuations in the quality of outcomes among HVHs, even between different years. Therefore, it was hypothesized that using the number of cases as a predictor of high-quality outcomes may lead to overestimation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years old
  • any pancreatic resection procedure
  • operated at any German hospital

排除标准

  • any transplantation procedure
  • Inpatient admission for organ removal
  • no information on sex
  • no information on age

结局指标

主要结局

In-hospital mortality

时间窗: within 30 days

Patient died during or after surgery

次要结局

未报告次要终点

研究者

发起方
Richard Hunger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Richard Hunger

Principal Investigator

Medizinische Hochschule Brandenburg Theodor Fontane

相似试验

Pancreatic Surgery - Optimal Caseload Thresholds and... | 临床试验