EPeCS: Epidemiology of Perioperative Care in Sweden

Sponsor

Linkoeping University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05560815

Collaborator

Region Östergötland (Other)

1,500,000

Enrollment

Location

Anticipated Duration (Months)

31927.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Procedure: Any surgical procedure

Detailed Description

Specific aim for each substudy:

Epidemiology of Perioperative Care in Sweden
Risk factors for mortality after acute hip fracture surgery
Healthcare need after surgery
outcomes after urgent and emergency surgery
impact of estimated glomerular filtration rate (eGFR) on survival after elective surgery
effect of angiotensin receptor blocker (ARB) and angiotensin converting enzyme inhibitor (ACEi) non-resumption on postoperative outcome
impact of socioeconomic status
impact of university hospital status
effect of body mass index (BMI)
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

EPeCS - Epidemiology of Perioperative Care in Sweden 2015-2020

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
The Swedish surgical population All adult patients (≥18 years) undergoing any surgical procedure registered in SPOR during 1 January 2015 - 31 December 2020.	Procedure: Any surgical procedure Might differ for substudies.

Arm

Intervention/Treatment

The Swedish surgical population

All adult patients (≥18 years) undergoing any surgical procedure registered in SPOR during 1 January 2015 - 31 December 2020.

Procedure: Any surgical procedure

Might differ for substudies.

Outcome Measures

Primary Outcome Measures

30-day mortality [Mortality up to 30 days post-surgery]
all cause
90-day mortality [Mortality up to 90 days post-surgery]
all cause
One-year mortality [Mortality up to one year post-surgery]
all cause
Two-year mortality [Mortality up to two years post-surgery]
all cause
Survival at longest follow-up [Longest possible follow-up post-surgery]
Survival rate through study completion, an average of 3 years

Secondary Outcome Measures

Postoperative complications [30 days (short-term) and one year (long-term) post-surgery, respectively]
Any new ICD10-SE code specified in SPOR
Healthcare need [Two years post-surgery]
Number of primary care visits
Critical Care need [30 days post-surgery]
Admission to a critical care unit after surgery
Hospital readmission [30 days post-surgery]
Readmission to hospital care after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)