Adenoma Colon, Colonic Neoplasms, Colon Polyp, Serrated Polyp
Conditions
Keywords
colonoscopy, adenoma detection rate, colorectal cancer screening, new technology
Brief summary
Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.
Detailed description
This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All study team members will have a prior run-in phase of performing at least 5 AmplifEYE colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.
Interventions
DEVICEAmplifEYE
AmplifEYE colonoscopy
Sponsors
Our Lady of Maryknoll Hospital
Queen Elizabeth Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 50 to 79 years old * Scheduled for screening, surveillance or diagnostic colonoscopy
Exclusion criteria
* Colonic strictures * History of bowel surgery * Per-rectal bleeding within six weeks * Inflammatory bowel disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 1 day | number of patients in whom at least one adenoma could be found |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp detection rate | 1 day | number of patients in whom at least one polyp could be found |
| Serrated polyp detection rate | 1 day | number of patients in whom at least one serrated polyp could be found |
| caecal intubation rate | 1 day | number of patients in whom caecal intubation is acheived |
| caecal intubation time | 1 day | time beginning with the insertion of the colonoscope until reaching the caecum |
Countries
Hong Kong
Outcome results
None listed