Psycho-Social Outcomes Following Emergency Laparotomy

Emergency Laparotomy Clinical Trial

— POLO  

Official title:

Psycho-Social Outcomes Following Emergency Laparotomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05281627
• Other study ID #: 8160
• Status: Active, not recruiting
• Start date: October 15, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2023
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Emergency Laparotomy

Intervention

Other:
• Emergency Laparotomy
All patients undergoing Emergency Laparotomy

Locations

Country	Name	City	State
United Kingdom	Julie Cornish	Cardiff
United Kingdom	Royal Alexandra Hospital	Paisley	Renfrewshire

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	NHS Greater Glasgow and Clyde, The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in sexual function	Single question regarding change in sexual function (min 0; max 5), where greater score represents increased sexual impairment	12 months
Secondary	Change in employment status	Single question regarding change in employment status (yes/no).	12 months
Secondary	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