Effectiveness and Safety of the Colonoscopy Assisted by Endocuff vs. Standard in the Colorectal Cancer Screening
Condition: Cancer Colorectal
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the
      detection rate of adenomas thanks to the improved visibility produced by the retraction of
      the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF
      VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated
      adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety
      of its use will be estimated.
    

Detailed description: 
      The main objective of the colorectal cancer screening program (CRC) is the detection of the
      greatest number of precursor lesions of neoplasms as well as cancerous lesions established in
      the general population with an intermediate risk of presenting CRC. Within this program,
      colonoscopy is considered the diagnostic technique of choice due to its cost-effectiveness
      balance. However, it remains a technique that is not entirely perfect since the omission of
      injuries during the procedure constitutes the main reason for the appearance of interval
      cancers, with a clear correlation between the rate of detection of adenomas and their
      appearance.

      The vast majority of CRC arise from precancerous polyps, of which there are two main types:
      conventional adenomas and serrated polyps. Conventional adenomas are the most frequent polyps
      being responsible for the majority of CRC through the adenoma-carcinoma sequence. It should
      be taken into account that about 15-30% of sporadic CRC develops from serrated polyps through
      the serrated pathway of carcinogenesis, which is different from the traditional
      adenoma-carcinoma sequence. Endoscopic detection of serrated polyps is difficult due to their
      indistinguishable edges and flat or sessile morphology. In addition, they tend to be located
      in the right colon, a place that can be more difficult to reach in colonoscopy and examine
      completely.

      Therefore, the ultimate goal of CRC screening colonoscopy is to reduce the appearance of CRC,
      trying to maximize the detection of polyps and therefore the detection rate of adenomas. For
      this there are several technical factors of colonoscopy, preparation, imaging and external
      devices that try to achieve an increase in the rate of detection of adenomas.

      ENDOCUFF VISION® (Norgine Pharmaceuticals Ltd) is a medical device that is fixed at the
      distal end of the endoscope, improving its insertion in the intestine thanks to the action it
      exerts by flattening the folds and stabilizing the device. Its use is related to greater
      accuracy in the detection of adenomas, since it increases the visibility of the mucosa and
      thus decreases the number of polyps that may go unnoticed, increasing the detection rate of
      adenomas between 10 and 16 percentage points, according with published literature .

      Thus, the hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases
      the detection rate of adenomas thanks to the improved visibility produced by the retraction
      of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF
      VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated
      adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety
      of its use will be estimated.
    

Intervention name(s): Colonoscopy procedure with endocuff
Intervention type(s): Device
Intervention description(s): Colonoscopy procedure with the use of ENDOCUFF VISION
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: adenoma; colonoscopy; endocuff; screening