Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy
NCT ID: NCT01440543
Last Updated: 2013-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
420 participants
INTERVENTIONAL
2011-01-31
2011-09-30
Brief Summary
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This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Water/CO2
water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
Water immersion insertion AND CO2 insufflation
* room temperature water infused by water pump into the colon just to facilitate scope insertion
* CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection
Water/Air
Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
Water immersion insertion
* room temperature water infused by water pump into the colon just to facilitate scope insertion
* standard room air insufflation during colonoscope withdrawal and mucosal inspection
CO2/CO2
CO2 insufflation during both colonoscope insertion and withdrawal
CO2 insufflation
\- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
Air/Air
room air insufflation during both colonoscope insertion and withdrawal
No interventions assigned to this group
Interventions
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Water immersion insertion AND CO2 insufflation
* room temperature water infused by water pump into the colon just to facilitate scope insertion
* CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection
Water immersion insertion
* room temperature water infused by water pump into the colon just to facilitate scope insertion
* standard room air insufflation during colonoscope withdrawal and mucosal inspection
CO2 insufflation
\- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
Eligibility Criteria
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Inclusion Criteria
* provided written consent
Exclusion Criteria
* known diagnosis of inflammatory bowel disease
* chronic benzodiazepine use
* refusal of minimal sedation
18 Years
ALL
No
Sponsors
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Vitkovice Hospital
OTHER
Responsible Party
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Premysl Falt MD
Principal Investigator
Principal Investigators
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Premysl Falt, MD
Role: PRINCIPAL_INVESTIGATOR
Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
Locations
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Digestive Diseases Center - Vitkovice Hospital
Ostrava, , Czechia
Countries
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References
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Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
Other Identifiers
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DDC VN 01
Identifier Type: -
Identifier Source: org_study_id
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