Colonic Adenomatous Polyps Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02051465 -
Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM
|
N/A |