Psycho-Social Outcomes Following Emergency Laparotomy

NCT ID: NCT05281627

Last Updated: 2023-07-20

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

UNKNOWN

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2024-09-30

Brief Summary

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An emergency laparotomy (EmLap) is a life-saving operation; but the aftermath for those that do survive can be lifechanging. Each year, in excess of 25,000 EmLaps are performed in UK. A national effort, through the National Emergency Laparotomy Audit (NELA), has managed to improve peri-operative care, and reduce 30 day mortality from 1 in 4 to less than 1 in 10. Whilst this reduction should be commended, it also means that more patients are surviving with some form of new infirmity.

This infirmity may be short-lived and reversible in some, and yet others may transition into a permanent chronic disease state. The impact of EmLap on those individuals that "do not fully recover" is far-reaching and often interlinked, covering biological, social and psychological domains. This makes it difficult to describe the true problem, i.e. holistic morbidity and suggest an intervention to improve it.

The primary aim of this work is to describe the holistic morbidity of EmLap throughout the first year of a patient's recovery.

Detailed Description

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Conditions

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Emergency Laparotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Emergency Laparotomy Patients

All adult patients (18+) who have undergone Emergency Laparotomy surgery, are recovering well (no illness which is expected to limit life to \<6m post op) and have sufficient English-language and cognitive skills to complete the study questionnaires.

Emergency Laparotomy

Intervention Type OTHER

All patients undergoing Emergency Laparotomy

Family Caregivers

Adult (18+) family members, close friend or caregivers of the individual who has received EmLap treatment have sufficient English-language and cognitive skills to complete the study questionnaires.

No interventions assigned to this group

Interventions

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Emergency Laparotomy

All patients undergoing Emergency Laparotomy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years or above
* Able to communicate in English
* Cognitively able to complete the questionnaire
* Able to provide informed voluntary consent
* Undergone an EmLap during admission
* Clinical team anticipate to be "medically fit for discharge" within 48 hours (of consent)

Exclusion Criteria

* Any terminal diagnosis in which the clinical team do not anticipate life expectancy to exceed 6 months from the time of surgery
* Acutely unwell at the time of recruitment. These patients may still be eligible and can be re-screened and recruited at a later date, should their condition improve.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

The Royal College of Surgeons of England

OTHER

Sponsor Role collaborator

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Alexandra Hospital

Paisley, Renfrewshire, United Kingdom

Site Status

Julie Cornish

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Silva L, Abbas Mohamed S, Meggy A, Ng JH, Torkington J, Moug S, Watts T, Bisson J, Cornish JA. Psychosocial outcomes following emergency laparotomy (POLO) study: a study protocol for a multicentre mixed-methods prospective cohort study assessing the psycho-social outcomes following emergency laparotomy in adults. BMJ Open. 2024 Jul 9;14(7):e081821. doi: 10.1136/bmjopen-2023-081821.

Reference Type DERIVED
PMID: 38986553 (View on PubMed)

Other Identifiers

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8160

Identifier Type: -

Identifier Source: org_study_id

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