Clinical Trial: Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

Brief Summary: The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.

Detailed Summary:

Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc.

Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a "split bowel preparation", which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube.

The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic
Sponsor: University of California, Davis

Current Primary Outcome: Adenoma detection rate [ Time Frame: 1 year ]

The investigators will compare adenoma detection rate at completion of study across the 4 arms


Original Primary Outcome: Adenoma detection rate [ Time Frame: 1 year ]

We will compare adenoma detection rate at completion of study across the 4 arms


Current Secondary Outcome:

  • Proximal adenoma detection rate [ Time Frame: 1 year ]
    The investigators will compare proximal adenoma detection rate at completion of study across the 4 arms
  • Polyp detection rate [ Time Frame: 1 year ]
    The investigators will compare polyp detection rate at completion of study across the 4 arms
  • Cecal intubation rate [ Time Frame: 1 year ]
    The investigators will compare cecal intubation rate at completion of study across the 4 arms
  • Withdrawal time [ Time Frame: 1 year ]
    The investigators will compare colonoscopy withdrawal time rate at completion of study across the 4 arms
  • Major complications (perforation, bleeding requiring transfusion) [ Time Frame: 1 year ]
    The investigators will compare major complications at completion of study across the 4 arms


Original Secondary Outcome:

  • Proximal adenoma detection rate [ Time Frame: 1 year ]
    We will compare proximal adenoma detection rate at completion of study across the 4 arms
  • Polyp detection rate [ Time Frame: 1 year ]
    We will compare polyp detection rate at completion of study across the 4 arms
  • Cecal intubation rate [ Time Frame: 1 year ]
    We will compare cecal intubation rate at completion of study across the 4 arms
  • Withdrawal time [ Time Frame: 1 year ]
    We will compare colonoscopy withdrawal time rate at completion of study across the 4 arms
  • Major complications (perforation, bleeding requiring transfusion) [ Time Frame: 1 year ]
    We will compare major complications at completion of study across the 4 arms


Information By: University of California, Davis

Dates:
Date Received: January 25, 2016
Date Started: January 2016
Date Completion:
Last Updated: May 24, 2017
Last Verified: May 2017