Clinical trial NCT05281627: Psycho-Social Outcomes Following Emergency Laparotomy
Official title: Psycho-Social Outcomes Following Emergency Laparotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergency Laparotomy
Keywords: Emergency Laparotomy
Laparotomy
Surgical Outcomes
Psychosocial
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: NHS Greater Glasgow and Clyde
name: The Royal College of Surgeons of England
First posted: 2022-03-16
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D)
timeFrame: 12 months
Secondary outcomes:
measure: Establishing the patient definition of 'Recovery' following Emergency Laparotomy using qualitative methods
timeFrame: 12 months
measure: Change in Fatigue Severity Score
timeFrame: 12 months
measure: Change in Body Mass Index
timeFrame: 12 months
measure: Change in Rockwood Frailty Score
timeFrame: 12 months
measure: Change in Gastro-Intestinal Quality of Life Index
timeFrame: 12 months
measure: Change in International Trauma Questionnaire score
timeFrame: 12 months
measure: Change in Patient Health Questionnaire score
timeFrame: 12 months
measure: Change in Generalised Anxiety Disorder assessment score
timeFrame: 12 months
measure: Changes in Community Integration Questionnaire score
timeFrame: 12 months
measure: Change in sexual function
timeFrame: 12 months
measure: Change in employment status
timeFrame: 12 months
measure: The changes in care burden as assessed by the Modified Caregiver Strain Index (MCSI)
timeFrame: 12 months
Other outcomes:
measure: Overall patient experience of Emergency Laparotomy care as assessed by the NHS Wales Experience Questionnaire
timeFrame: 12 months
measure: Number of patient points of care
timeFrame: 12 months
Locations:
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
state: Renfrewshire
city: Cardiff
country: United Kingdom
facility: Julie Cornish
Study officials:
References: