Dalin Tzu Chi General Hospital
Chiayi City, Taiwan, 622
NCT Number: NCT01535326
In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).
This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Chiayi City, Taiwan, 622
All procedures will be recorded and stored as digital files.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
insufflate air during the insertion of colonoscopy
infuse water during insertion, aspirate water during withdrawal
infuse and remove water during insertion phase of colonoscopy
Time frame: up to 12 months
proportion of patients without insertion pain during colonoscopy
Time frame: 9 to 12 months
The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Time frame: 9 to 12 months
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Time frame: 9 to 12 months
the number of participants with at least one adenoma in each of the study groups.
Time frame: one month
telephone follow up for post-procedure discomforts and 30 day complication rate
Dalin Tzu Chi General Hospital
Other
Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial
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