Cap-assisted Water Immersion Versus Water Immersion Colonoscopy
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|ClinicalTrials.gov Identifier: NCT01547247|
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : January 28, 2013
Last Update Posted : October 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope Procedure: water immersion colonoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
Experimental: cap-assisted water immersion colonoscopy
Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope
Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
Active Comparator: water immersion colonoscopy
Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: water immersion colonoscopy
Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
- Cecal Intubation Time [ Time Frame: 3 months ]The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.
- Patient Comfort During Insertion Phase of the Colonoscopy [ Time Frame: 3 months ]
- Success Rate of Minimal Sedation Colonoscopy [ Time Frame: 3 months ]A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547247
|Digestive Diseases Center, Vitkovice Hospital|
|Ostrava, Czech Republic, 703 84|
|Principal Investigator:||Premysl Falt, MD||Digestive Diseases Center, Vitkovice Hospital|