Warm Water Versus Room Temperature Water Immersion Colonoscopy
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|ClinicalTrials.gov Identifier: NCT01582178|
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : August 1, 2013
Last Update Posted : September 20, 2013
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.
The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.
The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: Warm Water Immersion Colonoscopy Procedure: Cool Water Immersion Colonoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Warm Water Immersion Colonoscopy
Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: Warm Water Immersion Colonoscopy
Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
Active Comparator: Cool Water Immersion Colonoscopy
Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: Cool Water Immersion Colonoscopy
Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
- Cecal Intubation Time [ Time Frame: 3 months ]
- Cecal Intubation Time [ Time Frame: 1-30 ]= 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 ]
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): NCT01582178
|Digestive Diseases Center, Vitkovice Hospital|
|Ostrava, Czech Republic, 703 84|
|Principal Investigator:||Premysl Falt, MD||Digestive Diseases Center, Vitkovice Hospital|