The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.
Problem statement: In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection. Research question/hypothesis: Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients? Study design: Parallel group, single blinded randomised controlled trial Study participants: Patients attending for colonoscopy under the bowel cancer screening programme Planned sample size: 534 Planned study period: 12 months Primary objective: To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
534
Colonoscopy performed with endo-cuff attached to the colonoscope
Standard colonoscopy without end-cuff
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom
Number of polyps detected per patient
Time frame: 1 month (when pathology report available)
Cancer detection rate
Time frame: 1 month (when pathology report available)
Polyp detection rate
Time frame: 1 month (when pathology report available)
Adenomas per patient
Time frame: 1 month (when pathology report available)
Adenoma detection rate
Time frame: 1 month (when pathology report available)
Caecal intubation rate
will be recorded at the time of the procedure
Time frame: 1 day
Total procedure time - from scope insertion to removal
will be recorded at the time of the procedure
Time frame: 1 day
Time taken to reach caecum
will be recorded at the time of the procedure
Time frame: 1 day
Time taken to withdraw scope (from caecum to removal of scope)
will be recorded at the time of the procedure
Time frame: 1 day
Patient comfort score
will be recorded at the time of the procedure
Time frame: 1 day
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