Water-aided Colonoscopy in Inflammatory Bowel Disease Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01933867|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : November 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Procedure: Water immersion Procedure: Air insufflation insertion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Water immersion colonoscopy
Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: Water immersion
Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.
Active Comparator: Air insufflation colonoscopy
Standard room air insufflation during both colonoscope insertion and withdrawal.
Procedure: Air insufflation insertion
Other Name: Room air insufflation during colonoscope insertion.
- Success rate of unsedated colonoscopy [ Time Frame: at the end of each colonoscopy ]Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.
- Discomfort during colonoscopy [ Time Frame: at the end of each colonoscopy ]Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).
- Cecal intubation time [ Time Frame: while reaching the cecum ]Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.
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): NCT01933867
|Digestive Diseases Center, Vitkovice Hospital|
|Ostrava, Czech Republic, 703 84|