NCT03856957

Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Hospital Beatriz Ângelo · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Serrated Lesion
• Adenoma
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Endocuff colonoscopy	Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
DEVICE	control	colonoscopy without endocuff

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-03-30
• Completion: 2019-07-01
• First posted: 2019-02-27
• Last updated: 2021-02-16

Locations

1 site across 1 country: Portugal