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

December 5, 2024 updated by: Rebecka Ahl Hulme, Region Stockholm

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Undergoing emergency laparotomy due to general surgical indication

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital serious complications
Time Frame: 30 days
Severity measured through Clavien-Dindo classification
30 days
Long-term mortality
Time Frame: 1 year
1 year
Quality of life questionnaires
Time Frame: 1 year
As measured through questionnaires at 1 month, 3 months and up to 1 year post-operatively.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Investigators

  • Principal Investigator: Rebecka Ahl Hulme, MD PhD, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 12, 2022

First Submitted That Met QC Criteria

November 12, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2022-9097

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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