A Phase 4 interventional study of Hyoscine Butyl Bromide 20mg/2 ml i.v. and Saline 2 ml i.v. in Colonic Adenomas, sponsored by Valduce Hospital. Status unknown at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-01.
Sponsored by Valduce Hospital · Phase 4, Interventional, and Diagnostic
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.
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).
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 400 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Valduce Hospital is the lead sponsor of 26 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.
Drug: Saline 2 ml i.v.
Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation
Also known as: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.
Administration of Saline 2 ml at time of caecal intubation
Also known as: Saline
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
Time frame: 5 months
Tolerability of HBB
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).
Time frame: this outcome will be evaluated at the end of colonoscopy
This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Valduce Hospital