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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DK068936 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Capital Digestive Care, LLC | OTHER |
| University of Pennsylvania | OTHER |
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The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.
Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing colonoscopy | Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy Force Monitor | Device | Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak push force is increased in patients receiving propofol as compared to conscious sedation. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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All adult male and female patients between the ages of 30 and 75 presenting to the participating sites for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Louis Y Korman, M.D. | Capital Digestive Care, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center, Gastroenterology | Washington D.C. | District of Columbia | 20057 | United States | ||
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| Georgetown University |
| OTHER |
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| Chevy Chase Endoscopy Center |
| Chevy Chase |
| Maryland |
| 20815 |
| United States |
| Univeristy of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |