BACKGROUND AND AIMS: EndoCuff is a disposable device applied to standard colonoscopes to improve mucosal visualization. Randomized parallel trials have shown that EndoCuff increases the adenoma detection rate (ADR). The primary aim of this study was to compare the ADR between EndoCuff-assisted colonoscopies (EAC) and standard colonoscopies within a randomized back-to-back trial. METHODS: This was a single-center randomized crossover study (NCT02374515) involving adult patients undergoing screening, surveillance, or diagnostic colonoscopy. Participants received back-to-back standard colonoscopies and EACs in a random order, performed by the same endoscopist. All polyps were excised, but only those proven at histology to be adenomas were considered for analysis. RESULTS:From February 2015 to March 2016, a total of 288 patients were enrolled, and 274 were included in the per-protocol analysis. Compared with standard colonoscopies, EACs increased the ADR (29.6% vs 26.3%; P < .01) and the number of diagnosed adenomas (176 vs 129; P < .01), particularly in the left (73 vs 46; P < .01) and right sides of the colon (83 vs 63; P < .01). EAC increased the detection of adenomas <5 mm (129 vs 84; P < .01), but no difference was found with regard to larger lesions. In 7.3% of patients, findings of EndoCuff shortened the surveillance interval determined by standard colonoscopy findings. EndoCuff caused 7 mucosal erosions (2.5% of patients), requiring a mucosal adrenaline injection in 1 case. CONCLUSIONS: The use of EndoCuff increases the number of identified adenomas, primarily small adenomas in the left and right sides of the colon. This increases the ADR and allows a better definition of the surveillance program. (Clinical trial registration number: NCT02374515.).
RCT Entities:
BACKGROUND AND AIMS: EndoCuff is a disposable device applied to standard colonoscopes to improve mucosal visualization. Randomized parallel trials have shown that EndoCuff increases the adenoma detection rate (ADR). The primary aim of this study was to compare the ADR between EndoCuff-assisted colonoscopies (EAC) and standard colonoscopies within a randomized back-to-back trial. METHODS: This was a single-center randomized crossover study (NCT02374515) involving adult patients undergoing screening, surveillance, or diagnostic colonoscopy. Participants received back-to-back standard colonoscopies and EACs in a random order, performed by the same endoscopist. All polyps were excised, but only those proven at histology to be adenomas were considered for analysis. RESULTS: From February 2015 to March 2016, a total of 288 patients were enrolled, and 274 were included in the per-protocol analysis. Compared with standard colonoscopies, EACs increased the ADR (29.6% vs 26.3%; P < .01) and the number of diagnosed adenomas (176 vs 129; P < .01), particularly in the left (73 vs 46; P < .01) and right sides of the colon (83 vs 63; P < .01). EAC increased the detection of adenomas <5 mm (129 vs 84; P < .01), but no difference was found with regard to larger lesions. In 7.3% of patients, findings of EndoCuff shortened the surveillance interval determined by standard colonoscopy findings. EndoCuff caused 7 mucosal erosions (2.5% of patients), requiring a mucosal adrenaline injection in 1 case. CONCLUSIONS: The use of EndoCuff increases the number of identified adenomas, primarily small adenomas in the left and right sides of the colon. This increases the ADR and allows a better definition of the surveillance program. (Clinical trial registration number: NCT02374515.).