Clinical Trial: EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
Brief Summary:
The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.
The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.
The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.
Detailed Summary:
Sponsor: Helios Albert-Schweitzer-Klinik Northeim
Current Primary Outcome: adenoma detection rate [ Time Frame: 25 minutes ]
Original Primary Outcome: overall polyp detection rate [ Time Frame: 25 minutes ]
Current Secondary Outcome:
- polyp detection rate [ Time Frame: 1 Week ]
- number of LGIN and HGIN adenomas detected [ Time Frame: one week ]LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
- polyp distribution [ Time Frame: 25 minutes ]
- procedure time [ Time Frame: 25 Minutes ]
- withdrawal time [ Time Frame: 10 Minutes ]without intervention time due to polypectomy
- ileum intubation rate [ Time Frame: 10 minutes ]
- total colonoscopy rate [ Time Frame: 25 minutes ]
- adverse events [ Time Frame: 25 minutes ]perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy
Original Secondary Outcome:
- adenoma detection rate [ Time Frame: 1 Week ]
- number of LGIN and HGIN adenomas detected [ Time Frame: one week ]LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
- polyp distribution [ Time Frame: 25 minutes ]
- procedure time [ Time Frame: 25 Minutes ]
- withdrawal time [ Time Frame: 10 Minutes ]without intervention time due to polypectomy
- ileum intubation rate [ Time Frame: 10 minutes ]
- total colonoscopy rate [ Time Frame: 25 minutes ]
- adverse events [ Time Frame: 25 minutes ]perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy
Information By: Helios Albert-Schweitzer-Klinik Northeim
Dates:
Date Received: January 6, 2014
Date Started: January 2014
Date Completion:
Last Updated: September 12, 2014
Last Verified: August 2014