Clinical Trial: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Brief Summary: The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Detailed Summary:

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.


Sponsor: South Tyneside NHS Foundation Trust

Current Primary Outcome: Adenoma detection rate [ Time Frame: 10 months ]

A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean adenomas detected per procedure [ Time Frame: 10 months ]
    A difference in mean adenomas detected per procedure between both groups
  • Rate of cuff exchange [ Time Frame: 10 months ]
    The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups
  • Effect on duration of caecal intubation rates [ Time Frame: 10 months ]
    Duration of complete withdrawal time in procedures where no polyps are detected between both groups
  • Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires [ Time Frame: 10 months ]
    Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).
  • Increase in surveillance colonoscopies caused by increased adenoma detection rate [ Time Frame: 10 months ]
    Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups
  • Number of proximal sessile serrated polyps by histology [ Time Frame: 10 months ]
    Number of of proximal sessile serrated polyps in both groups
  • Polyp location [ Time Frame: 10 months ]
    Distribution of polyps in the colon in both groups by location
  • Adenoma detection rate of BCSP and non-BCSP endoscopists [ Time Frame: 10 months ]
    Adenoma detection rate of BCSP and non-BCSP colonoscopists
  • Change in adenoma detection rate of each endoscopist during the course of the trial [ Time Frame: 10 months ]
    Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.
  • Adenoma detection rate of individual endoscopist before and after trial commencement [ Time Frame: 10 months ]
    Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.


Original Secondary Outcome:

  • Mean adenomas detected per procedure [ Time Frame: 10 months ]
    A difference in mean adenomas detected per procedure between both groups
  • Rate of cuff exchange [ Time Frame: 10 months ]
    The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups
  • Effect on duration of caecal intubation rates [ Time Frame: 10 months ]
    Duration of complete withdrawal time in procedures where no polyps are detected between both groups
  • Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires [ Time Frame: 10 months ]
    Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).
  • Increase in surveillance colonoscopies caused by increased adenoma detection rate [ Time Frame: 10 months ]
    Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups
  • Number of proximal sessile serrated polyps by histology [ Time Frame: 10 months ]
    Number of of proximal sessile serrated polyps in both groups
  • Polyp location [ Time Frame: 10 months ]
    Distribution of polyps in the colon in both groups by location
  • Adenoma detection rate of BCSP and non-BCSP endoscopists (note to commentator: we are looking at the adenoma detection rate of 2 different groups of endoscopists, BCSP and non BCSP, there is only one measure that is being made, thank you) [ Time Frame: 10 months ]
    Adenoma detection rate of BCSP and non-BCSP colonoscopists
  • Change in adenoma detection rate of each endoscopist during the course of the trial [ Time Frame: 10 months ]
    Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.
  • Adenoma detection rate of individual endoscopist before and after trial commencement [ Time Frame: 10 months ]
    Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.


Information By: South Tyneside NHS Foundation Trust

Dates:
Date Received: September 10, 2015
Date Started: November 2014
Date Completion: June 2016
Last Updated: September 15, 2015
Last Verified: September 2015