Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy (Water/CO2)
|ClinicalTrials.gov Identifier: NCT01440543|
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.
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).
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Procedure: Water immersion insertion AND CO2 insufflation Procedure: Water immersion insertion Procedure: CO2 insufflation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||September 2011|
water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
Procedure: Water immersion insertion AND CO2 insufflation
Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
Procedure: Water immersion insertion
CO2 insufflation during both colonoscope insertion and withdrawal
Procedure: CO2 insufflation
- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
No Intervention: Air/Air
room air insufflation during both colonoscope insertion and withdrawal
- Success Rate of Minimal Sedation Colonoscopy [ Time Frame: six months ]Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.
- Success Rate of Minimal Sedation Colonoscopy [ Time Frame: 6 months ]A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale  (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.
- Patient Comfort During the Procedure and During First 24 Hours After Procedure [ Time Frame: six months ]Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440543
|Digestive Diseases Center - Vitkovice Hospital|
|Ostrava, Czech Republic, 703 84|
|Principal Investigator:||Premysl Falt, MD||Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic|