BADCaP
Research type
Research Study
Full title
Bile acid diarrhoea after laparoscopic cholecystectomy
IRAS ID
249381
Contact name
Ramesh Arasaradnam
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Bile acid diarrhoea occurs in up to 12% of patients who have their gallbladder removed. The reason for this diarrhoea occurring is still unknown, as are the reasons why it develops in some people but not in others. When this diarrhoea develops it may also effect the lipid levels in the blood, and high lipid levels increase the risk of heart disease and stroke. Thus our research aims to find the reason why patients develop diarrhoea, who is more at risk, and how this affects blood lipid levels. This may lead to letting people know their risk prior to surgery and potentially even being able to start preventative medication to reduce lipid levels in high risk patients. It will also lead to faster diagnosis of bile acid diarrhoea when it occurs after surgery as there may be a delay of more than 2 years in the diagnosis.
This study will take place at University Hospitals Coventry and Warwickshire NHS Trust. The study will involve two groups; the study group will consist of those having their gallbladder removed and the control group having ‘other’ surgery.
Participants will first be contacted via telephone by a member of the research team, to inform them about the study at UHCW – and if interested they will be sent an invitation letter, participant information sheet and consent form. If the patient agrees, they will be sent the documents via mail one or two weeks before their pre-op assessment. This way, the patient will have sufficient time to decide participating or not.
Written informed consent for participation will be taken at pre-operative assessment or surgical outpatient clinic, by a member of the study team. Before taking consent, a participant information sheet will be given about the study. A full overview of risks and benefits will be given. A consent form has been created for the purpose of the study, one specifically for the study group and another for the control group. Patients will be informed that if they choose not to participate in the study, their care will not be affected in any way. The patient will also be informed that they are free to withdraw from the study at any time without giving a reason; their care will not be affected in any way. A translator may be required if a patient does not speak English’
As part of the patient’s pre-operative assessment, they will be required to have a blood test. If they agree to participate, the patient will have additional blood, stool and urine samples taken as well as completion of a questionnaire; which is additional to their normal clinical care. In the study group, a sample of the gallbladder and/or liver tissue will be taken if the patient consents to this and the surgeon deems it safe to do so.
At 3 months post-operatively, the patient will have a follow up visit, which is an additional visit. During this follow up, the patient will have blood, stool and urine tests taken with completion of a questionnaire. After this, the patient will have a 6 month telephone follow up; which will consist of completion of a questionnaire. This will then be the end of the study for the participant. Any patients developing diarrhoea, defined as passing stool more than 3 times a day types 5-7 according to the Bristol stool chart, will be offered further testing – SeHCAT and Colonoscopy, which is offered as part of the patient’s routine.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0395
Date of REC Opinion
25 Jan 2019
REC opinion
Further Information Favourable Opinion