Improved Adenoma Detection Rate Using a Novel Colonoscopic Distal Attachment: A Multicenter Randomized Controlled Trial.

ABSTRACT

INTRODUCTION: To evaluate the effect of Embrella, a novel-designed colonoscopic distal attachment, on adenoma detection rate (ADR) and adenoma per colonoscopy (APC), compared with standard colonoscopy in routine practice. METHODS: All consecutive participants who underwent routine colonoscopic examinations at 3 endoscopy centers in China were enrolled. Participants were randomly assigned in a 11 ratio to the Embrella-assisted colonoscopy (EAC) or standard colonoscopy (SC) groups. ADR, APC, inspection time, pain scores, and adverse events were recorded. RESULTS: Overall, 1,179 participants were randomized into the EAC (n = 593) and SC groups (n = 586). EAC increased the overall ADR from 24.6% to 34.2% ( P < 0.001) and improved APC from 0.44 to 0.64 ( P = 0.002). Subgroup analyses indicated that EAC significantly improved ADR for adenomas < 10 mm (13.8% vs 8.5%, P = 0.004 for 5-9 mm and 27.0% vs 17.2%, P < 0.001 for < 5 mm), nonpedunculated adenomas (26.6% vs 18.8%, P < 0.001), and adenomas in the transverse (10.8% vs 6.1%, P = 0.004) and left colon (21.6% vs 13.7%, P < 0.001). APC in the subgroup analyses was consistent with ADR. The mean inspection time was shorter with EAC (6.52 vs 6.68 minutes, P = 0.046), with no significant impact on participants' pain scores ( P = 0.377). Moreover, no EAC-related adverse events occurred. DISCUSSION: EAC significantly increased ADR and APC compared with SC, particularly for adenomas <10 mm, nonpedunculated adenomas, and adenomas in the transverse and left colon.