Clinical Trial: Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study

Brief Summary: The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.

Detailed Summary: 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).
Sponsor: Valduce Hospital

Current Primary Outcome: Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) [ Time Frame: 5 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerability of HBB [ Time Frame: this outcome will be evaluated at the end of colonoscopy ]

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).


Original Secondary Outcome: Same as current

Information By: Valduce Hospital

Dates:
Date Received: May 7, 2012
Date Started: January 2012
Date Completion: June 2012
Last Updated: May 31, 2012
Last Verified: May 2012