Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon
Condition: Colonic Adenomatous Polyps
MeSH terms: Adenomatous Polyps
Study type: Interventional

Summary: 
      Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer.
      However, colonoscopy causes significant abdominal discomfort and abdominal pain during and
      after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and
      pain are mostly caused by air insufflation and intubation difficulties during advancement of
      the colonoscope in order the reach the cecum.

      Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the
      colonoscope and will eliminate the need for colonic distention with the air or CO2, which can
      shortened the length of the procedure, reduce patient's discomfort and can decrease amount of
      sedatives and analgesics used during colonoscopy.
    

Detailed description: 
      The goal of this study is to evaluate effectiveness and safety of a "Visualization" Balloon
      for performance of colonoscopy.

      Our hypothesis is that, use of "Visualization" Balloon will decrease colonic distention,
      patient's discomfort, use of sedatives and analgetics during procedure and will simplify the
      performance of colonoscopy resulting in shortening of procedure time and increasing the rate
      of cecal intubation.

      Specific aims of the study:

        1. To compare procedure time and effectiveness of the "Visualization" Balloon colonoscopy
           with traditional CO2-insufflation colonoscopy.

        2. To compare safety profiles between traditional CO2-insufflation colonoscopy and
           colonoscopy using the "Visualization" Balloon.

      4 STUDY ENDPOINTS 4.1 Primary Outcome To compare the mean cecal intubation time achieved with
      "Visualization" Balloon colonoscopy, with the mean cecal intubation time achieved with
      standard colonoscopy using CO2 insufflation.

      4.2 Secondary Outcomes

      To compare "Visualization" Balloon colonoscopy with standard CO2-insufflation colonoscopy in
      regards of:

        1. Total amount of carbon dioxide (CO2) gas for colonic insufflation used during the
           procedure.

        2. Ease of colonoscope insertion.

        3. The length of the colonoscope when it reaches the cecum. 4 Colonoscope withdrawal time
           and total procedure time.

      5. Cecal intubation rate. 6. Total dosage of analgesics and sedative during procedure. 7.
      Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24
      hours post procedure.

      8. Complications during and after colonoscopy. 9. Polyp detection rate.
    

Intervention name(s): Visualization balloon; Traditional CO2 insufflation colonoscopy
Intervention type(s): Device; Device
Intervention description(s): The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.; Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: colonoscopy; cecal intubation; carbon dioxide insufflation