Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study
Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion
criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous
intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure
and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB
i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the
administered drug. The endoscopist was asked to inspect the right, transverse and left colon
for at least 2 min for each segment. The number, size and location of polyps were recorded
as well as the occurrence episodes of tachycardia (defined as bpm>140). As indirect
estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC
(difference in the abdominal circumference measured before and after colonoscopy) was also
calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the
patient was measured by means of a VA scale (range 0-100).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
5 months
No
Spinzi Giancarlo, MD
Study Director
Gastroenterology Unit, Ospedale Valduce, Como, Italy.
Italy: The Italian Medicines Agency
HBB-1
NCT01609855
January 2012
June 2012
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