Improvement in Adenoma Detection Rate with Distal Attachment Device Endo-Wing Assisted Colonoscopy: A Randomized Control Trial

Aim Endo-WingTM is a silicone rubber device with 6 wing-like projections attached at the end of the colonoscope that provides superior visualization by flattening the colonic fold and helps to maintain a central view of the colonoscope during withdrawal. This study aims to compare the adenoma detection rate (ADR) between standard colonoscopy and Endo-WingTM-assisted colonoscopy. Methods This is a single-center, single-blind, parallel-group, randomized, actively controlled, exploratory clinical trial conducted between July 2019 and April 2020. Participants symptomatic of colorectal cancer (CRC) or with a history of adenoma and under active surveillance were included, whilst those with known colonic strictures, tumors, active colitis, previous history of polyposis syndrome, had colostomy/ileostomy and BPPS score of 0 were excluded. Participants were subsequently randomized to receive standard colonoscopy (n=96), and Endo-Wing™ assisted colonoscopy (n=96) in a 1:1 ratio using a central block randomization method of varying block sizes. The primary endpoint was the ADR and the differences between the two groups were evaluated using univariable statistical methods. Results The ADR, the number of adenomas and the size of adenomas in the Endo-Wing™-assisted colonoscopy group were significantly higher compared to standard colonoscopy (P=0.005, 0.035, 0.035, respectively). Caecal intubation rates are similar in both groups (P>0.999). The proportions of colonoscopy requiring increased sedation and standard sedation were similar in both groups (P=0.613). No adverse effects of bleeding, perforation and device dislodgement were reported in both groups. Conclusion: This study concludes that Endo-Wing™ assisted colonoscopy improves ADR compared to standard colonoscopy.