ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care (ACUTE)

October 3, 2023 updated by: Region Skane
Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

At Skåne University Hospital approximately 6000 individuals are treated for acute abdominal diseases each year. Given the high number of patients, there is an urgent need to optimize acute surgical care. Lower complication rates would decrease hospital stay, health care costs as well as personal suffering.

Assessment instruments for risks and frailty are not validated for the acute setting and the investigators hypothesize there is room for improvement in prophylactic interventions and risk assessment. The investigators will study cohorts of patients with three different surgical diagnosis: acute pancreatitis, gastrointestinal bleeding and perforated ulcer aiming to identify risk factors for complications or death and to investigate assessment tools in this population. Using propensity score analysis, the investigators will try to identify treatment options associated with better outcome for subcohorts defined by frailty, comorbidity, age or gender. Specific factors of interest include: time to- and kind of treatment, handling of ongoing pharmacological therapy (anticoagulants, corticosteroids) and need for further treatments on a long time basis. The results from this project will be used in a future prospective study where prophylactic treatments and specific treatment options are studied.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden, 20502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to to Skåne University hospital in need of acute surgical care between 2009-2019

Description

Inclusion Criteria: Patients admitted to Skåne University hospital in need of acute surgical care -

Exclusion Criteria: Below 18 years old

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild acute pancreatitis
Patients treated with mild acute pancreatitis during the study period
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Moderate acute pancreatitis
Patients treated with moderate acute pancreatitis during the study period
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Severe acute pancreatitis
Patients treated with severe acute pancreatitis during the study period
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Acute gastrointestinal bleeding
Patients treated with acute gastrointestinal bleeding during the study period
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Perforated ulcer
Patients treated with perforated ulcer during the study period
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Older than 70 years
Patients older than 70 years
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Less than 70 years
Patients younger than 70 years
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Prothrombotic medications
Patients on prothrombotic medications
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Frail patients
Patients with increased frailty score
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision
Reintervention group
Patients in need of reintervention
Other: Observational study of different treatments and time to treatment
Different treatment based on the clinical decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 5 years
Defined by Swedish registers
5 years
Reintervention
Time Frame: 5 years
Defined by medical records
5 years
Recurrent disease
Time Frame: 5 years
Defined by medical records
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lengths of hospital stay
Time Frame: 5 years
defined by medical records
5 years
Number of interventions
Time Frame: 5 years
defined by medical records
5 years
complications
Time Frame: 5 years
defined by medical records and Swedish Registers
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Lund University

Investigators

  • Principal Investigator: Sara Regnér, PhD, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-03583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared after publication of studies from this trial upon request from publishers or other researchers. Only coded data will be shared and all sharing will be done according to the GDPR regulations.

IPD Sharing Time Frame

Study protocol will be available during 2022. SAP will be available during 2023.

IPD Sharing Access Criteria

After papers from this study have been published Upon request from publishers or researchers with a motivated scientific purpose or a motivated research question Only in accordance with GDPR regulations

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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