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NCT Number: NCT05623176

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

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.

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Key information

Conditions

Abdomen, Acute Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing emergency laparotomy due to general surgical indication

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. In-hospital mortality

    Time frame: 30 days

Secondary outcomes

  1. In-hospital serious complications

    Time frame: 30 days

    Severity measured through Clavien-Dindo classification

  2. Long-term mortality

    Time frame: 1 year

  3. Quality of life questionnaires

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecka Ahl Hulme, MD PhD

CONTACT

[email protected]

0046812373212

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study 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?

Acronym: LAPTOP

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Nov 21, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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