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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing emergency laparotomy due to general surgical indication

Disqualifiers

Children under 16

Trauma laparotomy

Vascular, urological or gynaecological indication for laparotomy

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Standardised laparotomy care

    Other intervention

    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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Old routine of non-standardised laparotomy care0 interventions
Group B: New routine of standardised laparotomy care1 intervention

Trial outcomes

Primary outcomes

1

In-hospital mortality

Time frame
30 days

Secondary outcomes

1

In-hospital serious complications

Severity measured through Clavien-Dindo classification

Time frame
30 days
2

Long-term mortality

Time frame
1 year
3

Quality of life questionnaires

As measured through questionnaires at 1 month, 3 months and up to 1 year post-operatively.

Time frame
1 year

Other outcomes

Sponsors and contacts

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