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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visualization balloon | Experimental | Colonoscopy performed with the use of "Visualization" balloon |
|
| Traditional CO2-insufflation colonoscopy | Active Comparator | Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visualization balloon | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cecal intubation time | Time required to reach cecum | Immediately |
| Measure | Description | Time Frame |
|---|---|---|
| Length of colonoscope when it reaches cecum | Total length of colonoscope when it reaches cecum | Immediately |
| Ease of colonoscope insertion | Easy of colonoscope insertion to cecum |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of carbon dioxide used | Total amount of carbon dioxide used during colonoscopy | Immediately |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey V Kantsevoy, MD, PhD | Mercy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
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|
| Traditional CO2 insufflation colonoscopy | Device | Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon |
|
| Immediate |
| Dose of analgesics and sedatives used | Dose of analgesics and sedatives used during insertion and total dose for the entire procedure | Immediately |
| Patient satisfaction | Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure. | Immediately and in 24 hours |
| Total procedure time | Total time required to complete colonoscopy | Immediately |