Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)
Condition: Colorectal Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition
      White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal
      Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the
      detection of colorectal adenomas

      Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed
      with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and
      HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone

      Design: Multicenter, Prospective, randomized controlled study

      Primary Aim: To compare the proportion of subjects with at least one adenoma detected during
      HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL
      colonoscopy with Endocuff Vision.

      Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy
      versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with
      Endocuff Vision.

      To compare the detection rates for polyp subtypes (including advanced adenomas, serrated
      polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time,
      and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment
      cap versus HDWL colonoscopy with Endocuff Vision.
    

Detailed description: 
      Hypothesis and specific aims of the Study

      We hypothesize that the detection rate of patients with colorectal adenomas will be higher
      with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff
      Vision compared to HDWL colonoscopy alone.

      Primary Aim:

      To compare the proportion of subjects with at least one adenoma detected during HDWL
      colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL
      colonoscopy with Endocuff Vision.

      Secondary Aims:

        1. To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL
           colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff
           Vision.

        2. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated
           polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal
           time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal
           attachment cap versus HDWL colonoscopy with Endocuff Vision.

      Methodology:

      This will be a prospective, randomized controlled study. Subjects referred for screening or
      surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 3
      arms, i.e. HDWL colonoscopy HDWL colonoscopy with Reveal® cap or HDWL colonoscopy with
      Endocuff Vision.

      Enrollment:

      A member of the research team will approach a potential subject to discuss participation in
      the study, including background of the proposed study, inclusion and exclusion criteria,
      benefits and risks of the procedures and follow-up. If this is of interest to the subject,
      the informed consent form is discussed and presented. The subject must sign the consent form
      prior to enrollment. This form will have prior approval of the study site's Institutional
      Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the
      study.

      Length of the study:

      The duration of the study is expected to be approximately 12 months. Enrollment of study
      patients will cease when approximately 1227 patients have been enrolled.

      Inclusion criteria

        -  Referral for screening or surveillance colonoscopy

        -  Ability to provide informed consent

      Exclusion criteria

        -  Prior history of colon cancer

        -  History of inflammatory bowel disease

        -  Prior surgical resection of any part of the colon

        -  Use of anti-platelet agents or anticoagulants that precludes the removal of polyps
           during the procedure

        -  History of polyposis syndrome or HNPCC

        -  Inability to give informed consent

        -  Family history of colon cancer in a first degree relative < 60 years or two first degree
           relatives with colorectal cancer

      For three groups, moderate sedation will be administered in a standard fashion with
      intravenous midazolam, meperidine or fentanyl prior to undergoing colonoscopy.

      The colonoscope (HDWL colonoscope or HDWL colonoscope with Reveal® cap or HDWL colonoscope
      with Endocuff Vision) will be inserted and cecum will be intubated. Photo documentation of
      the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal
      of the colonoscope.

      The time from the point of insertion of the colonoscope into the rectum to the intubation of
      cecum will be recorded with a stop watch by a research coordinator and will be documented as
      the "insertion time".

      The time spent in inspecting the mucosa during withdrawal of the colonoscope will be
      documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will
      be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is
      being removed to ensure that the withdrawal time is the actual representation of the mucosal
      inspection time. Meticulous technique will be employed during the withdrawal phase with
      special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral
      folds, flexures and valves.

      All polyps detected will be documented: size, location, and morphology (using the Paris
      classification - Appendix A). Photo documentation of the polyps will be performed.

      Polyps will then be removed with a biopsy forceps or snare and sent for histopathological
      evaluation, each in a separate jar and labeled accordingly.

      The bowel preparation will be evaluated and graded according to previously reported criteria
      using the Boston Bowel Preparation Scale (Appendix B). Complications including any mucosal
      trauma from the high definition colonoscope alone or with high definition colonoscope with
      Reveal® cap or Endocuff Vision, perforation or gastrointestinal bleeding (requiring
      intervention) will be recorded for three groups.
    

Intervention name(s): Colonoscopy; distal Cap; Endocuff
Intervention type(s): Procedure; Device; Device
Intervention description(s): Using an instrument called colonoscope which is used to detect colonic polyps; Using an instrument called cap at end of colonoscope which is used to straighten colon folds; Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three Arm Randomized Control Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic