Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NHS Greater Glasgow and Clyde | OTHER |
| The Royal College of Surgeons of England | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Laparotomy | Other | All patients undergoing Emergency Laparotomy |
|
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Paisley | Renfrewshire | PA2 9PJ | United Kingdom | ||
| Julie Cornish |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38986553 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| Cardiff |
| CF14 4XW |
| United Kingdom |