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临床试验/NCT05560815
NCT05560815进行中(未招募)不适用

EPeCS - Epidemiology of Perioperative Care in Sweden 2015-2020

Linkoeping University1 个研究点 分布在 1 个国家目标入组 1,500,000 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,500,000
试验地点
1
主要终点
90-day mortality

研究概览

简要总结

The Epidemiology of Perioperative Care in Sweden (EPeCS) study is a registry-based, retrospective extensive analysis of the whole adult (≥18 years) surgical population in Sweden during six full years, 1 January 2015 - 31 December 2020. Patients are retrieved from the Swedish Perioperative Registry (SPOR) which has full national coverage of public healthcare.

The study aspire to integrate pre-, peri- and postoperative components of the whole perioperative process as well as process, patient, anaesthesia and surgical factors. This allows for careful risk-adjustment and is a major strength of the project. This will require cross-matching data from several national quality registries.

EPeCS will serve as a database to be used as the foundation for several substudies that are to be conducted (10 at the present moment). Specific study focuses and aims are described in the "Detailed Description" section below.

The present study aims to provide a comprehensive audit of the surgical population in Sweden, and to identify factors that are of importance for outcome. The investigators aim to identify factors that will allow a better prediction of outcome, if they are modifiable, and if they are different for different lengths of follow-up. The ultimate goal is to provide hypotheses for directed therapies (eg. different types of anaesthesia), processes (eg. designated around-the-clock hip-fracture surgical teams), postoperative care (eg. extended PACU care instead of intensive care) in order to decrease suffering and increase cost-efficacy in Swedish healthcare.

详细描述

Specific aim for each substudy:

  1. Epidemiology of Perioperative Care in Sweden
  2. Risk factors for mortality after acute hip fracture surgery
  3. Healthcare need after surgery
  4. outcomes after urgent and emergency surgery
  5. impact of socioeconomic status
  6. impact of university hospital status
  7. effect of body mass index (BMI)
  8. effect of post-anaesthesia care unit (PACU) stay
  9. incidence and outcomes of Perioperative Cardiac Arrest (PO-CA)

All these 9 specific areas have knowledge gaps regarding perioperative care.

Although there are 9 specific aims in this project, the same dataset (or parts thereof) from SPOR will be used for all substudies. The investigators will include all adult patients (≥18 years) undergoing any surgical procedure, except for the substudies where specific populations are prespecified, which are substudy 2: hip fracture surgery; substudy 4: urgent and emergency procedures; substudies 5,6 and 10: elective procedures with planned overnight stay; substudies 7 and 8: large joint surgery (hip and knee replacements), acute hip fracture surgery, colectomy, mastectomy, transurethral resection of the prostate (TUR-P) and prostatectomy.

Outcome measures might also differ between substudies.

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

  • Underwent any surgical procedure in Sweden during the time period 1 Jan 2015 - 31 Dec 2020
  • Registered in the Swedish Perioperative Registry (SPOR)
  • ≥18 years of age
  • Swedish social security number (to enable follow-up)

排除标准

  • incorrect social security number
  • incomplete mortality data
  • the patient has chosen to opt-out of the register
  • The first two exclusion criteria are applied because they prevent correct follow-up of the primary outcome measure (mortality)

结局指标

主要结局

90-day mortality

时间窗: Mortality up to 90 days post-surgery

all cause

30-day mortality

时间窗: Mortality up to 30 days post-surgery

all cause

Two-year mortality

时间窗: Mortality up to two years post-surgery

all cause

One-year mortality

时间窗: Mortality up to one year post-surgery

all cause

Survival at longest follow-up

时间窗: Longest possible follow-up post-surgery

Survival rate through study completion, an average of 3 years

次要结局

  • Hospital readmission(30 days post-surgery)
  • Healthcare need(Two years post-surgery)
  • Critical Care need(30 days post-surgery)
  • Postoperative complications(30 days (short-term) and one year (long-term) post-surgery, respectively)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Rasmus Åhman

Principal Investigator

Linkoeping University

研究点 (1)

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