Colorectal Neoplasms Clinical Trial
— B-ADENOMAOfficial title:
BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Verified date | September 2018 |
Source | South Tyneside NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.
Status | Completed |
Enrollment | 3221 |
Est. completion date | February 13, 2018 |
Est. primary completion date | February 13, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 61 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 years and over 2. Referral for screening flexible sigmoidoscopy 3. Ability to give informed consent Exclusion Criteria: 1. Absolute contraindications to flexible sigmoidoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes 4. Known colonic strictures 5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage) 6. Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants which have not been stopped for the procedure as these will preclude polyp removal 9. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Bolton NHS Foundation Trust | Bolton | |
United Kingdom | Gloucestershire Hospitals NHS Foundation Trust | Cheltenham | |
United Kingdom | Dorset Healthcare University NHS Trust | Dorchester | |
United Kingdom | County Durham and Darlington NHS Foundation Trust | Durham | |
United Kingdom | University Hospitals of Morecambe Bay NHS Foundation Trust | Kendal | |
United Kingdom | Kettering General Hospital NHS Trust | Kettering | |
United Kingdom | North West London Hospitals NHS Trust | London | |
United Kingdom | Northumbria Healthcare NHS Foundation Trust | North Shields | |
United Kingdom | Oxford Health NHS Trust | Oxford | |
United Kingdom | Portsmouth Hospitals NHS Trust | Portsmouth | |
United Kingdom | Pennine Acute Hospitals NHS Trust | Rochdale | |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | |
United Kingdom | South Tyneside NHS Foundation Trust | South Shields | Tyne And Wear |
United Kingdom | North Tees and Hartlepool NHS Trust | Stockton on Tees | |
United Kingdom | West Hertfordshire Hospitals NHS Trust | Watford | |
United Kingdom | The Royal Wolverhamptom NHS Trust | Wolverhampton |
Lead Sponsor | Collaborator |
---|---|
South Tyneside NHS Foundation Trust | ARC Medical Design Ltd, Norgine |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma Detection Rate | Proportion of examinations expressed as a percentage where at least one adenoma is found | Day of procedure | |
Secondary | Mean adenomas detected per procedure | Number of adenomas found in each procedure | Day of procedure | |
Secondary | Rate of cuff exchange | How often the cuff is removed | Day of procedure | |
Secondary | Non-inferiority of complete withdrawal time in procedures where no polyps are detected | Length of procedure in minutes and seconds | Day of procedure | |
Secondary | Compare overall procedure time between groups | Length of procedure in minutes and seconds | Day of procedure | |
Secondary | Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation). | Proportion of examinations expressed as a percentage where at least one adenoma is found | Day of procedure | |
Secondary | Compare the rate of discovered cancers between groups | Number of cancers found | On histology check 48-72 hours post procedure | |
Secondary | Examination extent between groups based on presumed anatomical location with a straight endoscope | Anatomical location | Day of procedure | |
Secondary | Examination extent between groups based on distance of insertion in centimetres with a straight endoscope | Depth of insertion in centimetres | Day of procedure | |
Secondary | Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort | Numerical 4 point patient comfort score | Day of procedure | |
Secondary | Identify any difference in future colonoscopic workload produced by increased ADR in terms of number of patients referred for full colonoscopy between the EAFS and SFS groups. | Number of additional colonoscopies required | Day of procedure | |
Secondary | Compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR to assess any learning curve effect. | Proportion of examinations expressed as a percentage where at least one adenoma is found | 18 months | |
Secondary | Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used. | Proportion of examinations expressed as a percentage where at least one adenoma is found | 18 months |
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