Clinical Trial: Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

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

Official Title: A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon

Brief 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 Summary:

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 in
Sponsor: Mercy Medical Center

Current Primary Outcome: Cecal intubation time [ Time Frame: Immediately ]

Time required to reach cecum


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of colonoscope when it reaches cecum [ Time Frame: Immediately ]
    Total length of colonoscope when it reaches cecum
  • Ease of colonoscope insertion [ Time Frame: Immediate ]
    Easy of colonoscope insertion to cecum
  • Dose of analgesics and sedatives used [ Time Frame: Immediately ]
    Dose of analgesics and sedatives used during insertion and total dose for the entire procedure
  • Patient satisfaction [ Time Frame: Immediately and in 24 hours ]
    Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
  • Total procedure time [ Time Frame: Immediately ]
    Total time required to complete colonoscopy


Original Secondary Outcome: Same as current

Information By: Mercy Medical Center

Dates:
Date Received: April 11, 2014
Date Started: March 2014
Date Completion: December 2017
Last Updated: February 15, 2017
Last Verified: February 2017