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

NCT ID: NCT05623176

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abdomen, Acute

Keywords

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Emergency laparotomy General surgery Clinical outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Old routine of non-standardised laparotomy care

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

No interventions assigned to this group

New routine of standardised laparotomy care

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

Standardised laparotomy care

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Undergoing emergency laparotomy due to general surgical indication

Exclusion Criteria

* Children under 16
* Trauma laparotomy
* Vascular, urological or gynaecological indication for laparotomy
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rebecka Ahl Hulme

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecka Ahl Hulme, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Rebecka Ahl Hulme, MD PhD

Role: CONTACT

Phone: 0046812373212

Email: [email protected]

Facility Contacts

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Rebecka Ahl Hulme, MD PhD

Role: primary

Anna Ohlsson, MD PhD

Role: backup

Other Identifiers

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K2022-9097

Identifier Type: -

Identifier Source: org_study_id