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 ]

completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.


Original Primary Outcome: overall polyp detection rate [ Time Frame: 25 minutes ]

completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.


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