Adenoma, Colorectal Cancer, Serrated Lesion
Conditions
Keywords
Serrated Lesion, Endocuff, Detection
Brief summary
Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.
Interventions
DEVICEEndocuff colonoscopy
Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
DEVICEcontrol
colonoscopy without endocuff
Sponsors
Hospital Beatriz Ângelo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
\- Outpatients undergoing elective colonoscopies
Exclusion criteria
* Known polyposis syndromes * Personal colorectal cancer history * Previous colorectal surgery * Severe diverticulosis * Colonic stricture * Inflammatory bowel disease * Primary sclerosing cholangitis * Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average number of serrated lesions ≥ 10 mm detected per colonoscopy | immediate | Average number of serrated lesions ≥ 10 mm detected per colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average number of serrated lesions < 10 mm detected per colonoscopy | immediate | Average number of serrated lesions \< 10 mm detected per colonoscopy |
| Average number of adenomas detected per colonoscopy | immediate | Average number of adenomas detected per colonoscopy |
| Adenoma detection rate | immediate | Number of patients with at least one adenoma/total number of participants |
| Adenocarcinoma detection rate | immediate | Number of patients with at least one adenocarcinoma/total number of participants |
| Serrated lesions detection rate | immediate | Number of patients with at least one serrated lesion/total number of participants |
| Cecal incubation time | immediate | time from the rectum to cecum in minutes |
| Withdrawal time | immediate | time from the cecum to the rectum in minutes |
| Incidence of procedure related adverse events | immediate | Number of adverse events |
| Cecal intubation rate | immediate | Proportion of colonoscopies with cecal intubation x100 |
Countries
Portugal
Outcome results
None listed