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Epidemiology of Perioperative Care in Sweden

Active, not recruiting
Conditions
Surgery
Interventions
Procedure: Any surgical procedure
Registration Number
NCT05560815
Lead Sponsor
Linkoeping University
Brief Summary

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.

Detailed Description

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 estimated glomerular filtration rate (eGFR) on survival after elective surgery

6. effect of angiotensin receptor blocker (ARB) and angiotensin converting enzyme inhibitor (ACEi) non-resumption on postoperative outcome

7. impact of socioeconomic status

8. impact of university hospital status

9. effect of body mass index (BMI)

10. effect of post-anaesthesia care unit (PACU) stay

All these 10 specific areas have knowledge gaps regarding perioperative care.

Although there are 10 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.

National Quality Registries that will provide data for EPeCS, presented as "register (registry holder)":

* Swedish Perioperative Registry, SPOR (Uppsala Clinical Research Centre, UCR)

* Longitudinal integrated database for health insurance and labour market studies, LISA (Statistics Sweden)

* Swedish National Inpatient Register (the National Board of Health and Welfare)

* Swedish National Outpatient Register (the National Board of Health and Welfare)

* Swedish Drug Register (the National Board of Health and Welfare)

* Swedish Cause of death Register (the National Board of Health and Welfare)

The impetus for this project comes from the realization that surgery is not just a discrete event - it is part of a continuum of a larger journey of illness and health. The investigators hope to gain a comprehensive understanding of those patients who are at risk of poor outcome, their risk of death and burden of healthcare need after surgery.

Additional substudies might emerge.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1500000
Inclusion Criteria
  • 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)
Exclusion Criteria
  • 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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
The Swedish surgical populationAny surgical procedureAll adult patients (≥18 years) undergoing any surgical procedure registered in SPOR during 1 January 2015 - 31 December 2020.
Primary Outcome Measures
NameTimeMethod
30-day mortalityMortality up to 30 days post-surgery

all cause

90-day mortalityMortality up to 90 days post-surgery

all cause

Two-year mortalityMortality up to two years post-surgery

all cause

One-year mortalityMortality up to one year post-surgery

all cause

Survival at longest follow-upLongest possible follow-up post-surgery

Survival rate through study completion, an average of 3 years

Secondary Outcome Measures
NameTimeMethod
Hospital readmission30 days post-surgery

Readmission to hospital care after discharge

Healthcare needTwo years post-surgery

Number of primary care visits

Critical Care need30 days post-surgery

Admission to a critical care unit after surgery

Postoperative complications30 days (short-term) and one year (long-term) post-surgery, respectively

Any new ICD10-SE code specified in SPOR

Trial Locations

Locations (1)

Department of Anaesthesia and Intensive Care, Linkoeping University Hospital

🇸🇪

Linköping, Östergötland, Sweden

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