Colorectal Adenoma, Colorectal Cancer
Conditions
Keywords
Adenoma, polyp, colonoscopy.
Brief summary
Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope. The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.
Interventions
DEVICEEndocuff attachment
Endocuff
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme. * Ability to understand the nature and requirements of the study and to provide written informed consent.
Exclusion criteria
* Contraindication to undergo standard colonoscopy. * Severe active colitis. * Known colonic stricture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with adenomas and cancers detected | immediate |
Secondary
| Measure | Time frame |
|---|---|
| Caecal intubation time | Immediate |
Other
| Measure | Time frame |
|---|---|
| Caecal intubation rate | immediate |
| Polyp detection rate | immediate |
Countries
United Kingdom
Outcome results
None listed