Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
Procedure: water immersion
Procedure: water exchange
Procedure: air insufflation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation|
- Proportions of patients requiring sedation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- patient pain during insertion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- post-procedure discomforts and 30 days complication rate [ Time Frame: one month ] [ Designated as safety issue: No ]telephone follow up for post-procedure discomforts and 30 days complication rate
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: water immersion
infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.
|Procedure: water immersion|
Experimental: water exchange
infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase
|Procedure: water exchange|
Active Comparator: air insufflation
standard colonoscopy using traditional air insufflation during insertion
|Procedure: air insufflation|
The patients will be allocated into 3 groups by computerized randomization. In group A (water exchange), water will be infused and removed at the same time throughout the entire colon during the insertion phase with the air pump turned off. In group B (water immersion), water will be infused in the insertion phase and removed in the withdrawal phase. The water will be used mainly to open the lumen, without attempting to clear the colon contents. In group A and B, warm-to-touch water will be infused mainly infused through the accessory channel of the colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air insufflation not used until the cecum has been reached. . In group C, air insufflation will be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal compression and change of patient position will be utilized at the discretion of the colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be undertaken during the withdrawal phase.
During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none, 10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort. For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter, the nurse will offer sedation, which the patients can accept or decline. If accepted, after an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan, Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an adequate level of sedation. The need of additional drug will be estimated by patient pain response (moans, grimaces and movements). Usually no more propofol will be added during the withdrawal phase. The initial amount of propofol, and those before and after arrival to the cecum will be recorded.
The following parameters will be evaluated and recorded on the patient data sheet: quality of bowel preparation, cecal intubation time, withdrawal time total procedure time, use of abdominal pressure, need for changing position, presence of polyps and reasons for incomplete colonoscopy.
The procedure will be recorded and stored as digital files.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699399
|Dalin Tzu Chi General Hospital||Recruiting|
|Chia-Yi, Taiwan, 622|
|Contact: Yu-Hsi Hsieh firstname.lastname@example.org|
|Principal Investigator: Yu-Hsi Hsieh, Dr.|
|Principal Investigator:||Yu-Hsi Hsieh, M.D.||Dalin Tzu Chi General Hospital|