Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
818
air insufflation during insertion phase colonoscopy
warm water irrigation during insertion phase colonoscopy
Servizio Endoscopia Digestiva
Iglesias, Carbonia-Iglesias, Italy
U.O.S.D. Diagnostica e Terapia Endoscopica
San Gavino Monreale, Medio Campidano (VS), Italy
number of patients undergoing complete unsedated or slightly sedated colonoscopy
number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V.
Time frame: 9 months
evaluation of pain and tolerability scores
Numeric rating scale, Verbal Descriptor Scale and Faces Pain Scale (0= no pain, 10 worst possible pain.) Hicks CL et al. Pain 2001;93:173-183. Bieri D. et al. Pain. 1990;41(2):138-50.
Time frame: 1 hour
percentage of caecum intubation
Time frame: 1 hour
time to reach caecum
Time frame: 1 hour
Adenoma detection rate
Proportion of patients with at least one adenoma of any size
Time frame: 9 months
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