Psycho-Social Outcomes Following Emergency Laparotomy

Study Overview
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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.

Official Title
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Psycho-Social Outcomes Following Emergency Laparotomy

Conditions
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Emergency Laparotomy

Intervention / Treatment
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* Other: Emergency Laparotomy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency Laparotomy Patients<br>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<br>* All patients undergoing Emergency Laparotomy<br>|
| Family Caregivers<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Laparotomy, Laparotomy, Surgical Outcomes, Psychosocial