Psycho-Social Outcomes Following Emergency Laparotomy

NCT05281627 | Unknown

• 1 other identifier: 8160
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 2

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.

Conditions

Emergency Laparotomy

Keywords

Emergency Laparotomy; Laparotomy; Surgical Outcomes; Psychosocial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Establishing the patient definition of 'Recovery' following Emergency Laparotomy using qualitative methods

  12 months

• Change in Fatigue Severity Score

  12 months

• Change in Body Mass Index

  12 months

• Change in Rockwood Frailty Score

  12 months

• Change in Gastro-Intestinal Quality of Life Index

  12 months

Other Outcomes (2)

• Overall patient experience of Emergency Laparotomy care as assessed by the NHS Wales Experience Questionnaire

  12 months

• Number of patient points of care

  12 months

Study Arms (2)

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

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.

Interventions

Emergency Laparotomy OTHER

All patients undergoing Emergency Laparotomy

Emergency Laparotomy Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• NHS Greater Glasgow and Clyde: collaborator
• The Royal College of Surgeons of England: collaborator

Study Sites (2)

Royal Alexandra Hospital

Paisley, Renfrewshire, PA2 9PJ, United Kingdom

Location

Julie Cornish

Cardiff, CF14 4XW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38986553 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: March 16, 2022
• Study Start: October 15, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)