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

Recruiting

• Conditions: Complication of Anesthesia; Complication of Surgical Procedure; Long Term Effects After Emergency Surgery; Long Term Effects After GI Bleeding; Risk Factors; Complication of Treatment
• Interventions: Other: Observational study of different treatments and time to treatment

• Registration Number: NCT05195697
• Lead Sponsor: Region Skane

Brief Summary

Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

Below 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Recurrent disease	5 years	Defined by medical records
Mortality	5 years	Defined by Swedish registers
Reintervention	5 years	Defined by medical records

Secondary Outcome Measures

Name	Time	Method
Lengths of hospital stay	5 years	defined by medical records
complications	5 years	defined by medical records and Swedish Registers
Number of interventions	5 years	defined by medical records

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Malmö, Skåne, Sweden