Emergency LaparotomyPOLONCT05281627
Psycho-Social Outcomes Following Emergency Laparotomy
An observational study of Emergency Laparotomy, run by Cardiff and Vale University Health Board at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Laparotomy
- What is being tested?
- Emergency Laparotomy
- How many people
- 175 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Oct 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Julie Cornish
Cardiff, CF14 4XW
Royal Alexandra Hospital
Paisley, Renfrewshire, PA2 9PJ
About this study
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
- Being tested
- Emergency Laparotomy
- Keywords
- Emergency Laparotomy, Laparotomy, Surgical Outcomes, Psychosocial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency LaparotomyOther
All patients undergoing Emergency Laparotomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (12)
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:
- what patients consider to constitute 'recovery' following emergency laparotomy B) what factors influence achieving 'recovery' C) the timelines linked to a) and b)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Change in sexual function
Single question regarding change in sexual function (min 0; max 5), where greater score represents increased sexual impairment
Measured: 12 months
Change in employment status
Single question regarding change in employment status (yes/no).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Oct 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- NHS Greater Glasgow and Clyde, The Royal College of Surgeons of England
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281627
- Sponsor's protocol ID
- 8160
- Acronym
- POLO
- Status last verified
- Mar 2023
- First submitted
- 29 Nov 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38986553
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-Social Outcomes Following Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT05281627
- Acronym / sponsor ID
- POLO / 8160
- Conditions
- Emergency Laparotomy
- Keywords
- Emergency Laparotomy, Laparotomy, Surgical Outcomes, Psychosocial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- NHS Greater Glasgow and Clyde, The Royal College of Surgeons of England
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Laparotomy Patients | – | Other: Emergency LaparotomyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency LaparotomyAll patients undergoing Emergency Laparotomy | Other | Emergency Laparotomy Patients |
Primary outcome
The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D)
Time frame: 12 months
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 secondary outcomes
Establishing the patient definition of 'Recovery' following Emergency Laparotomy using qualitative methods
Time frame: 12 months
Change in Fatigue Severity Score
Time frame: 12 months
Change in Body Mass Index
Time frame: 12 months
Change in Rockwood Frailty Score
Time frame: 12 months
Change in Gastro-Intestinal Quality of Life Index
Time frame: 12 months
Change in International Trauma Questionnaire score
Time frame: 12 months
Change in Patient Health Questionnaire score
Time frame: 12 months
Change in Generalised Anxiety Disorder assessment score
Time frame: 12 months
Changes in Community Integration Questionnaire score
Time frame: 12 months
Change in sexual function
Time frame: 12 months
Change in employment status
Time frame: 12 months
The changes in care burden as assessed by the Modified Caregiver Strain Index (MCSI)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 38986553Silva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Laparotomy, run by Cardiff and Vale University Health Board at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.