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Recruiting NCT05623176

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

Observational Abdomen, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standardised laparotomy care.
Who it may be relevant to
Registry conditions: Abdomen, Acute. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improvement in Patient Survival and Equality in Care Provision for General Surgery Patients Undergoing Emergency Laparotomy - Can This be Achieved Through the Implementation of Standardised Care Protocols?

Overview

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. what factors are associated with adverse post-operative events 2. are patients treated differently based on sex or age 3. how does quality of life look like and possibly change over the coarse of a year after surgery This is an evaluation of the current standard of care and the outcomes of this patient group prior to the implementation of a standardised care protocols for emergency laparotomy patients. Secondly, the study aims to, over time, compare results before and after the introduction of this standardised care protocol.

Interventions

  • Other Standardised laparotomy care
    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.

Primary outcome measures

  • In-hospital mortality [Time frame: 30 days]
Secondary outcome measures (3)
  • In-hospital serious complications [Time frame: 30 days]
  • Long-term mortality [Time frame: 1 year]
  • Quality of life questionnaires [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Undergoing emergency laparotomy due to general surgical indication

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Stockholm

Identifiers

NCT: NCT05623176 · K2022-9097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗