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Psycho-Social Outcomes Following Emergency Laparotomy

Psycho-Social Outcomes Following Emergency Laparotomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05281627
Acronym
POLO
Enrollment
175
Registered
2022-03-16
Start date
2021-10-15
Completion date
2024-09-30
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Laparotomy

Keywords

Emergency Laparotomy, Laparotomy, Surgical Outcomes, Psychosocial

Brief summary

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.

Interventions

All patients undergoing Emergency Laparotomy

Sponsors

NHS Greater Glasgow and Clyde
CollaboratorOTHER
The Royal College of Surgeons of England
CollaboratorOTHER
Cardiff and Vale University Health Board
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D)12 monthsPatient reported Quality of Life will be measured at 3 time points post-discharge. Reduction of EQ-5D 3-Level scale (min.5; max 15) and EQ-5D Visual Analogue Scale (min 0; max. 100) represent improved quality of life.

Secondary

MeasureTime frameDescription
Establishing the patient definition of 'Recovery' following Emergency Laparotomy using qualitative methods12 monthsSemi-structured qualitative interviews will be conducted with approximately 15 Emergency Laparotomy patients, at 6-months post-discharge from hospital. The interview will evaluate: A) what patients consider to constitute 'recovery' following emergency laparotomy B) what factors influence achieving 'recovery' C) the timelines linked to a) and b)
Change in Fatigue Severity Score12 monthsFatigue severity score (FSS) to assess physical health. Measured at 3 time-points post-operatively and scored from 9 (min.) to 63 (max.), with increase in total score represents greater fatigue severity/ reduced physical health.
Change in Body Mass Index12 monthsBody Mass Index (BMI) to assess physical health. Weight and Height will be recorded in kg and cm (respectively) at 3 time-points and BMI will be calculated and reported in terms of kg/m\^2.
Change in Rockwood Frailty Score12 monthsRockwood Frailty Score to asses physical health. Collected at 3 time-points and scored from 1 (min.) to 9 (max.), where greater score represents increased frailty. Only validated for use in the over 65's
Change in Gastro-Intestinal Quality of Life Index12 monthsGastro-intestinal Quality of Life Index (GIQLI) to assess in physical health. Collected at 3 time-points, total score calculated from 0 (min.) to 144 ( max.), where greater total score represents improved GI health related QoL.
Change in International Trauma Questionnaire score12 monthsInternational Trauma Questionnaire to assess mental-health. Collected at 3 timepoints. Scored in accordance with assessment guidance to determine clinical signs of (complex) Post-Traumatic Stress Disorder.
Change in employment status12 monthsSingle question regarding change in employment status (yes/no).
The changes in care burden as assessed by the Modified Caregiver Strain Index (MCSI)12 monthsCaregiver- reported burden will be measured at 3 timepoints post-discharge. Increase in total score of the Modified Caregiver Strain Index (MCSI) (min. 0; max. 26), represents greater burden on caregiver.
Change in Patient Health Questionnaire score12 monthsPatient Health Questionnaire (PHQ9) to assess mental-health. Collected at 3 timepoints and scored from 0 (min.) to 27 (max.), where greater score represents increased depression severity.
Change in Generalised Anxiety Disorder assessment score12 monthsGeneralised Anxiety Disorder assessment (GAD7) to assess mental-health. Measured at 3 timepoints from 0 (min.) to 21 (max.), where greater score represents increased anxiety severity.
Changes in Community Integration Questionnaire score12 monthsCommunity Integration Questionnaire (CIQ) to determine changes in social integration. Scored between 0 (min.) and 35 (max.), where greater score represents reduced social integration.
Change in sexual function12 monthsSingle question regarding change in sexual function (min 0; max 5), where greater score represents increased sexual impairment

Other

MeasureTime frameDescription
Overall patient experience of Emergency Laparotomy care as assessed by the NHS Wales Experience Questionnaire12 monthsPatient experience will be assessed at a 3 time-points during the course of their recovery at the end of the study using the NHS Wales Patient Experience questionnaire. Overall experience is measured on 10-point Likert scale (0-least satisfied, 10 most satisfied).
Number of patient points of care12 monthsIncidence of scheduled and unscheduled care will be measured over the course of the patients involvement in the project

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026