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

Complication of Surgical Procedure Clinical Trial

— ACUTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195697
• Other study ID #: 2019-03583
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 2030

Study information

• Verified date: October 2023
• Source: Region Skane
• Contact: Sara Regnér, PhD
• Phone: 040 33 10 00
• Email: sara.regner[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2030
• Est. primary completion date: December 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria: Below 18 years old

-

Related Conditions & MeSH terms

• Complication of Anesthesia
• Complication of Surgical Procedure
• Complication of Treatment
• Emergencies
• Risk Factors

Intervention

Other:
• Observational study of different treatments and time to treatment
Different treatment based on the clinical decision

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Defined by Swedish registers	5 years
Primary	Reintervention	Defined by medical records	5 years
Primary	Recurrent disease	Defined by medical records	5 years
Secondary	Lengths of hospital stay	defined by medical records	5 years
Secondary	Number of interventions	defined by medical records	5 years
Secondary	complications	defined by medical records and Swedish Registers	5 years