Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas
Condition: Sessile Serrated Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      This study evaluates whether the use of a disposable colonoscope attachment, Endocuff Vision,
      can increase the detection of sessile serrated adenomas. Participating patients will be
      randomized to receive either standard colonoscopy or colonoscopy with the Endocuff Vision.
    

Detailed description: 
      Colon cancer remains the second leading cause of death amongst both men and women in the
      United States(1). With the advent of screening colonoscopy, mortality from colorectal cancer
      has decreased, and colonoscopy is the current gold standard for colorectal cancer screening
      and prevention by removing adenomatous polyps.

      Different devices have been employed to assist the endoscopist in the detection of colon
      adenomas, as these lesions serve as precursors to colon neoplasia. One device of interest is
      the Endocuff Vision. The Endocuff Vision is a disposable device with a single row of soft,
      hair-like projections that aid in flattening colonic folds during colonoscope withdrawal to
      increase the detection of colon adenomas. Previous studies have compared endocuff-assisted
      colonoscopy to standard colonoscopy, and the results have indicated significant improvement
      in overall adenoma detection rates (ADR)(2-4). All of these studies have focused on the
      detection of conventional tubular adenomas as primary endpoints. However, there exists an
      additional serrated adenoma pathway that may give rise to about 15-20% of colon cancers (5).
      These lesions tend to be flatter with subtler features that make them harder to detect. A
      recent meta-analysis suggested that the endocuff was more effective at detecting sessile
      serrated adenomas compared to standard colonoscopy; however, these findings are derived from
      secondary data analyses (6). To the best of our knowledge, no study to date has examined the
      sessile serrated adenoma detection rate as a primary endpoint.

      Our previous study examined the differences in overall adenoma detection between
      endocuff-assisted and standard colonoscopy. Although there was no statistical difference in
      ADR between endocuff-assisted colonoscopy and standard colonoscopy, investigators did observe
      a numeric difference in sessile serrated adenoma detection rate (SSADR), 16.7% vs 23.8% (p =
      0.5) between standard colonoscopy and endocuff-assisted colonoscopy, respectively. Given the
      previous sample size was calculated to detect differences in overall ADR, the study was not
      powered to determine whether this observed difference in SSADR was significant.

      Therefore, the goal of the proposed study is to compare standard colonoscopy to
      endocuff-assisted colonoscopy in patients undergoing colonoscopy for colon cancer screening
      to determine differences in sessile serrated adenoma detection rates.
    

Intervention name(s): Endocuff Vision Assisted Colonoscopy
Intervention type(s): Device
Intervention description(s): Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.
Masking: Single (Participant)
Primary purpose: Diagnostic