Clinical Outcomes and Equality in Healthcare for Emergency General Surgery Patients Undergoing Emergency Laparotomy

NCT05623176 | Recruiting

• 1 other identifier: K2022-9097
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery. The main questions it aims to answer are:

1. 1.what factors are associated with adverse post-operative events
2. 2.are patients treated differently based on sex or age
3. 3.how does quality of life look like and possibly change over the coarse of a year after surgery

Conditions

Abdomen, Acute

Keywords

Emergency laparotomy; General surgery; Clinical outcomes

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  30 days

Secondary Outcomes (3)

• In-hospital serious complications

  30 days

• Long-term mortality

  1 year

• Quality of life questionnaires

  1 year

Study Arms (2)

Old routine of non-standardised laparotomy care

Group following the old routine of emergency laparotomy care i.e. no existing standardised care protocols.

New routine of standardised laparotomy care

Group which has been part of the hospital's new standardised care routine for emergency laparotomy.

Other: Standardised laparotomy care

Interventions

Standardised laparotomy care OTHER

This is a cohort study and no intervention as part of the study has been introduced. We are studying two groups and comparing the two before and after the introduction of a standardised laparotomy care protocol as part of a clinical quality improvement measure.

New routine of standardised laparotomy care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion of adult general surgical patients undergoing an emergency laparotomy during period 2015 and 2029. The cohort of 2015-2022 will be compared to the cohort of 2023-2029 in terms of general outcomes. The cohort of 2023-2029 will specifically be studied for any impact of emergency laparotomy on quality of life.

You may qualify if:

• Undergoing emergency laparotomy due to general surgical indication

You may not qualify if:

• Children under 16
• Trauma laparotomy
• Vascular, urological or gynaecological indication for laparotomy

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Rebecka Ahl Hulme, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecka Ahl Hulme, MD PhD

CONTACT

0046812373212; rebecka.ahl-hulme@regionstockholm.se

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: November 12, 2022
• First Posted: November 21, 2022
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

SE (1)