- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07014033
- Original Trial
Single-use Versus Multiple-use Endoscopes in Gastroenterology (SUMU-Endo)
Single-use Versus Multiple-use Endoscopes in Gastroenterology: Multi Methods Analysis to Balancing Infection Control and Environmental Impact
Gastroenterology is a branch of medicine that looks after people with problems in the gut (including the stomach and bowels) using an endoscope. An endoscope is a thin tube with a light and camera at the end, which is used to look inside bits of the body, for example the stomach, bile ducts (tubes that connect the liver and gallbladder to the bowel) or large bowel. Some have extra bits attached to take samples of tissue to look at under a microscope. These tubes are made mostly of plastic.
Around 1.5 million endoscopies are performed each year in the UK. In the NHS, most endoscopes are re-usable and are used hundreds of times after cleaning and disinfection. They must be very carefully cleaned and disinfected to reduce the risk of passing on infections to other patients as well as the healthcare staff who use the equipment. If endoscopes are cleaned and disinfected properly, the risk of infection will be very low. However there have been reports of infections, which may be related to disinfection not being done properly. Disposable single-use endoscopes are now available, designed to reduce the risk of infection. These are thought to be just as good as re-usable endoscopes. However, if we switch to disposable endoscopes, it may increase the cost to the NHS. There will also be an effect on the environment from using limited resources to make endoscopes, and get rid of them by incineration (burning) or burial in landfill waste.
The aim of this research is to provide evidence on the arguments for and against the use of single-use vs. multiple-use endoscopes in gastroenterology for NHS decision makers, especially regarding cost-effectiveness and effect on the environment. This will help the aim of the NHS in England to be "the world's first 'net zero' national health service.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Coventry, United Kingdom, CV2 2DX
- University Hospital Coventry and Warwickshire NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients who have attended or are scheduled to attend the endoscopy clinic at selected hospital sites.
Staff who work in the endoscopy pathway: doctors/nurses, decontamination technicians etc.
Description
Inclusion Criteria:
Patients
- Over the age of 18
- Patient has been invited to an NHS endoscopic clinic to undertake an upper GI endoscope procedure, including diagnostic endoscopies and the less complex therapeutic endoscopy.
- Patient is able to read and understand information provided
- Patient has capacity to provide consent
- Patient is able to participate in an interview. Staff
- Over the age of 18
- Employed by the NHS
- Working in relevant endoscopy unit - primary work involves the conduct of endoscopy and/or waste disposal services (decontamination or disposal).
Exclusion Criteria:
- Patient has received a lower GI endoscopy, e.g. colonoscopy or sigmoidoscopy
- Non-NHS service providers and receivers. (e.g., private diagnostic clinics)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients
Patients who have recieved an Upper GI endoscopy
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Staff
Staff working in the endoscopy pathway
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Qualitative Interview Study
Time Frame: 8 months
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Number of participants recruited to interview
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8 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RA627423
- 24/PR/0316 (Other Identifier: Research Ethics Commmittee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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