Epidemiology of Perioperative Care in Sweden

NCT05560815 | Active Not Recruiting

• 1 other identifier: EPeCS - ANOPIVA
• Study Type: observational
• Target: 1,500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Epidemiological study; Adverse effects; Operative surgical procedures; Perioperative process; Risk factors; Mortality; Postoperative complications

Outcome Measures

Primary Outcomes (5)

• 30-day mortality

  all cause

  Mortality up to 30 days post-surgery

• 90-day mortality

  all cause

  Mortality up to 90 days post-surgery

• One-year mortality

  all cause

  Mortality up to one year post-surgery

• Two-year mortality

  all cause

  Mortality up to two years post-surgery

• Survival at longest follow-up

  Survival rate through study completion, an average of 3 years

  Longest possible follow-up post-surgery

Secondary Outcomes (4)

• Postoperative complications

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

• Healthcare need

  Two years post-surgery

• Critical Care need

  30 days post-surgery

• Hospital readmission

  30 days post-surgery

Study Arms (1)

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

Interventions

Any surgical procedure PROCEDURE

Might differ for substudies.

The Swedish surgical population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult (≥18 years) patients that have undergone any type of surgical procedure during 1 Jan 2015 - 31 Dec 2020 and are registered in the Swedish Perioperative Registry (SPOR).

You may qualify if:

• 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)

You may not qualify if:

• incorrect social security number
• incomplete mortality data
• the patient has chosen to opt-out of the register

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator

Study Sites (1)

Department of Anaesthesia and Intensive Care, Linkoeping University Hospital

Linköping, Östergötland County, 50185, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle S Chew, MD, PhD

  Linkoeping University

  STUDY CHAIR

• Rasmus Åhman, MD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 29, 2022
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: December 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

SE (1)