Hospital Beatriz Ângelo
Lisbon, Loures, 2674-514, Portugal
NCT Number: NCT03856957
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.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Lisbon, Loures, 2674-514, Portugal
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
colonoscopy without endocuff
Time frame: immediate
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Time frame: immediate
Number of patients with at least one serrated lesion/total number of participants
Time frame: immediate
Average number of serrated lesions < 10 mm detected per colonoscopy
Time frame: immediate
Average number of adenomas detected per colonoscopy
Time frame: immediate
Number of patients with at least one adenoma/total number of participants
Time frame: immediate
Number of patients with at least one adenocarcinoma/total number of participants
Time frame: immediate
Proportion of colonoscopies with cecal intubation x100
Time frame: immediate
time from the rectum to cecum in minutes
Time frame: immediate
time from the cecum to the rectum in minutes
Time frame: immediate
Number of adverse events
Hospital Beatriz Ângelo
Other
Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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