Psycho-Social Outcomes Following Emergency Laparotomy (POLO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergency Laparotomy
• Intervention / Treatment: Other: Emergency Laparotomy

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Julie Cornish
  • Renfrewshire
    • Paisley, Renfrewshire, United Kingdom, PA2 9PJ
      • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is all patients who have undergone emergency laparotomy during their admission to hospital, are recovering well and approaching discharge. Participants will be recruited from hospital sites in Wales and Scotland.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Emergency Laparotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D)	Patient 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishing the patient definition of 'Recovery' following Emergency Laparotomy using qualitative methods	Semi-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)	12 months
Change in Fatigue Severity Score	Fatigue 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.	12 months
Change in Body Mass Index	Body 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.	12 months
Change in Rockwood Frailty Score	Rockwood 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	12 months
Change in Gastro-Intestinal Quality of Life Index	Gastro-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.	12 months
Change in International Trauma Questionnaire score	International 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.	12 months
Change in Patient Health Questionnaire score	Patient 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.	12 months
Change in Generalised Anxiety Disorder assessment score	Generalised 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.	12 months
Changes in Community Integration Questionnaire score	Community Integration Questionnaire (CIQ) to determine changes in social integration. Scored between 0 (min.) and 35 (max.), where greater score represents reduced social integration.	12 months
Change in sexual function	Single question regarding change in sexual function (min 0; max 5), where greater score represents increased sexual impairment	12 months
Change in employment status	Single question regarding change in employment status (yes/no).	12 months
The changes in care burden as assessed by the Modified Caregiver Strain Index (MCSI)	Caregiver- 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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient experience of Emergency Laparotomy care as assessed by the NHS Wales Experience Questionnaire	Patient 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).	12 months
Number of patient points of care	Incidence of scheduled and unscheduled care will be measured over the course of the patients involvement in the project	12 months

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: NHS Greater Glasgow and Clyde; The Royal College of Surgeons of England

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Laparotomy; Psychosocial; Emergency Laparotomy; Surgical Outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 8160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No