Managing gallstone disease in the elderly
| ISRCTN | ISRCTN12668840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12668840 |
| IRAS number | 301556 |
| Secondary identifying numbers | CPMS 52135, IRAS 301556 |
- Submission date
- 17/10/2022
- Registration date
- 16/12/2022
- Last edited
- 08/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Patients over 70 years old are very commonly admitted to the hospital with problems caused by gallstones, such as pain, infection, jaundice and pancreatitis (inflammation of the pancreas, a digestive organ which can get blocked by gallstones). Some people have their gallbladder removed during their initial admission and others are treated first with medical therapy (such as antibiotics or endoscopy) and then brought back later to have their gallbladder removed as a planned (or “elective”) operative. This usually prevents further problems caused by gallstones. For a number of reasons, including frailty or other medical problems, surgery is not considered the appropriate treatment for some patients.
Very little is known about what happens to these patients in the longer term – such as whether the gallstones do cause more problems and how this affects their quality of life. This study aims to follow up with patients who were admitted to the hospital with gallstone disease to assess how this has affected them for up to three years after their initial diagnosis and compare those who did and those who did not have surgery. Patients will be contacted regularly to ask whether they have any ongoing symptoms and how this affects their quality of life. This is an observational study which will not affect which treatment each patient receives – this will be decided as normal by the team treating them in the hospital. A better understanding of what happens to patients after surgical and non-surgical treatment would allow doctors to have more informed discussions with patients about the likely outcomes of each treatment and improve their ability to make a joint decision about whether surgery is the best option.
Who can participate?
Patients aged 70 years old and over who have been admitted to the hospital in an emergency with gallbladder problems
What does the study involve?
The treatment will be exactly the same whether a patient takes part or not. Information will be collected about the patient while they are in the hospital from their medical records and then they will be contacted by telephone 30 days, 1 year and 3 years after their admission to ask them some questions about how they are feeling, whether they have been admitted to hospital again with gallstones and about their quality of life. The research team may also contact their GP or access your medical notes at these time points in order to record details about their health relevant to the trial.
What are the possible benefits and risks of participating?
There are no direct benefits to you from taking part but we hope this will help us improve the way we treat older patients with gallstones in the future. There will be no disadvantage to you from taking part, as you will receive the same standard treatment regardless. The three follow up telephone calls should only take approximately 15 minutes each and you will not need to attend any appointments as part of the trial. There are no additional risks to you in this study.
Where is the study run from?
Wessex Research Collective (UK) and is sponsored by Portsmouth Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Rosetrees Trust (UK)
Who is the main contact?
Ms Amy Lord (UK)
amylord@nhs.net
Contact information
Public
Study Lead/Co-Ordinator (off-site)
Portsmouth Hospitals University NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)2392286000 |
|---|---|
| amylord@nhs.net |
Public
Study Co-Ordinator at PHU
Portsmouth Hospitals University NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)2392286000 |
|---|---|
| alexander.darbyshire@porthosp.nhs.uk |
Principal Investigator
Consultant Surgeon
Portsmouth Hospitals University NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
 ORCID ID |
0000-0001-5110-2371 |
|---|---|
| Phone | +44 (0)2392286000 |
| simon.toh@porthosp.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | 42612 MANGO patient info sheet v1.3 21March2022.pdf |
| Scientific title | Managing gallstone disease in the elderly: comparing quality of life and outcomes after operative and non-operative treatment |
| Study acronym | MANGO |
| Study hypothesis | Re-admission rate for patients with symptomatic gallstone disease managed non-operatively will be higher than those who have a cholecystectomy |
| Ethics approval(s) | 1. Approved 22/06/2022, HRA and Health and Care Research Wales (HCRW) (Address: not available; Tel: not available; approvals@hra.nhs.uk, HCRW.approvals@wales.nhs.uk), ref: 22/NS/0026 2. Approved 01/03/2022, North of Scotland Research Ethics Service (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK ; +44(0)1224 558458; gram.nosres@nhs.scot), ref: 22/NS/0026 |
| Condition | Upper gastrointestinal surgery |
| Intervention | Patients will be recruited to the study when they are admitted to the hospital with gallstone disease. The study will be explained to them and they will be asked to complete a consent form if they wish to take part. In patients who consent, data will be extracted from their medical records about their diagnosis, any operations and treatments they receive and the events during admission, such as complications. Patients will undergo standard treatment as determined by their medical team and no changes will be made as a result of participating in the study. Patients will be followed up by telephone 30 days, 1 year and 3 years after their initial admission to assess whether they have had further problems or complications and what their quality of life is like (using a standardised and validated questionnaire). Hospital records will also be re-assessed at these time points to gain information about any subsequent admissions, operations, etc. The group of patients who have surgery will be compared to those who do not. We will compare: 1. The number of patients who require readmission to the hospital due to gallstone disease for each group 2. The number of complications for each group of patients 3. The number of patients who die in each group 4. The quality of life for each group |
| Intervention type | Other |
| Primary outcome measure | To compare gallstone-related readmission rates among operative and non-operative groups (count [%]) measured by interrogating patient medical records at 30 days, 1 year and 3 years |
| Secondary outcome measures | 1. Morbidity: the number of patients who have complications (count [%) measured by interrogating patient medical records at the end of the study 2. Mortality: the number of patients who passed away (count [%]) measured by interrogating patient medical records at 30 days, 1 year and 3 years. 3. Quality of life measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at 30 days, 1 year and 3 years. |
| Overall study start date | 01/09/2021 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 70 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 260; UK Sample Size: 260 |
| Participant inclusion criteria | 1. Aged 70 years old and over 2. Admitted acutely to the hospital with a disorder caused by gallstones (i.e. biliary colic, cholecystitis, gallstone pancreatitis, choledocholithiasis or cholangitis) 3. Able to provide informed consent |
| Participant exclusion criteria | 1. Aged 69 years old and under 2. Unwilling or unable to give informed consent |
| Recruitment start date | 21/10/2022 |
| Recruitment end date | 10/10/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Cosham
Portsmouth
PO6 3LY
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Parkhurst Road
Newport
PO30 5TG
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Sponsor information
Hospital/treatment centre
C/o: Alice Mortlock
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)2392286000 |
|---|---|
| research.office@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/ |
"ROR" |
https://ror.org/009fk3b63 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Teresa Rosenbaum Golden Charitable Trust, Rosetrees
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | 1. Peer reviewed scientific journals 2. Conference presentation 3. Publication on a website |
| IPD sharing plan | The study datasets will be stored on secure servers in the Research Department at PHU and accessible to the relevant members of the research team. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 21/03/2022 | 19/10/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 1.3 | 12/10/2022 | 08/03/2024 | No | No |
Additional files
Editorial Notes
08/03/2024: Protocol (not peer reviewed) added.
17/10/2022: Trial's existence confirmed by the NIHR.
