Colonic Neoplasms, Colonic Polyps
Conditions
Keywords
Colonoscopy, early cancer detection, cancer screening
Brief summary
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.
Detailed description
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
Interventions
DEVICEEndo-cuff
Colonoscopy performed with endo-cuff attached to the colonoscope
OTHERStandard colonoscopy
Standard colonoscopy without end-cuff
Sponsors
Portsmouth Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients referred for colonoscopy under the national bowel cancer screening programme * Able to provide written informed consent
Exclusion criteria
* History of Inflammatory bowel disease * History of Hereditary non polyposis colorectal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of polyps detected per patient | 1 month (when pathology report available) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp detection rate | 1 month (when pathology report available) | — |
| Adenomas per patient | 1 month (when pathology report available) | — |
| Adenoma detection rate | 1 month (when pathology report available) | — |
| Caecal intubation rate | 1 day | will be recorded at the time of the procedure |
| Cancer detection rate | 1 month (when pathology report available) | — |
| Time taken to reach caecum | 1 day | will be recorded at the time of the procedure |
| Time taken to withdraw scope (from caecum to removal of scope) | 1 day | will be recorded at the time of the procedure |
| Patient comfort score | 1 day | will be recorded at the time of the procedure |
| Total procedure time - from scope insertion to removal | 1 day | will be recorded at the time of the procedure |
Countries
United Kingdom
Outcome results
None listed