NCT05195697

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2020Dec 2030

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

8.9 years

First QC Date

January 4, 2022

Last Update Submit

October 3, 2023

Conditions

Keywords

Emergency surgeryAcute surgeryComplicationsRisk factorsFrailtyAgeing

Outcome Measures

Primary Outcomes (3)

  • Mortality

    Defined by Swedish registers

    5 years

  • Reintervention

    Defined by medical records

    5 years

  • Recurrent disease

    Defined by medical records

    5 years

Secondary Outcomes (3)

  • Lengths of hospital stay

    5 years

  • Number of interventions

    5 years

  • complications

    5 years

Study Arms (10)

Mild acute pancreatitis

Patients treated with mild acute pancreatitis during the study period

Other: Observational study of different treatments and time to treatment

Moderate acute pancreatitis

Patients treated with moderate acute pancreatitis during the study period

Other: Observational study of different treatments and time to treatment

Severe acute pancreatitis

Patients treated with severe acute pancreatitis during the study period

Other: Observational study of different treatments and time to treatment

Acute gastrointestinal bleeding

Patients treated with acute gastrointestinal bleeding during the study period

Other: Observational study of different treatments and time to treatment

Perforated ulcer

Patients treated with perforated ulcer during the study period

Other: Observational study of different treatments and time to treatment

Older than 70 years

Patients older than 70 years

Other: Observational study of different treatments and time to treatment

Less than 70 years

Patients younger than 70 years

Other: Observational study of different treatments and time to treatment

Prothrombotic medications

Patients on prothrombotic medications

Other: Observational study of different treatments and time to treatment

Frail patients

Patients with increased frailty score

Other: Observational study of different treatments and time to treatment

Reintervention group

Patients in need of reintervention

Other: Observational study of different treatments and time to treatment

Interventions

Different treatment based on the clinical decision

Acute gastrointestinal bleedingFrail patientsLess than 70 yearsMild acute pancreatitisModerate acute pancreatitisOlder than 70 yearsPerforated ulcerProthrombotic medicationsReintervention groupSevere acute pancreatitis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, Skåne County, 20502, Sweden

RECRUITING

Related Publications (1)

  • Forsberg-Puckett A, Wurm Johansson G, Regner S. Presentation of gastrointestinal bleeding in patients with antithrombotic therapy, results from a consecutive retrospective cohort. Scand J Trauma Resusc Emerg Med. 2025 Sep 10;33(1):146. doi: 10.1186/s13049-025-01431-1.

MeSH Terms

Conditions

Frailty

Interventions

Time-to-Treatment

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sara Regnér, PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Regnér, PhD

CONTACT

Jenny Eckner, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 19, 2022

Study Start

January 1, 2020

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Study protocol will be available during 2022. SAP will be available during 2023.
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

Locations