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

Phase 4

• Conditions: Colonic Adenomas
• Interventions: Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.; Drug: Saline 2 ml i.v.

• Registration Number: NCT01609855
• Lead Sponsor: Valduce Hospital

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 Description

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).

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-31
• Last Update Submitted: 2012-05-31
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Posted: 2012-06-01
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• outpatients referred for colonoscopy

Exclusion Criteria

• glaucoma
• benign prostatic hyperplasia or urinary obstruction
• previous intestinal resection,
• ongoing therapy with tricyclic antidepressants
• chronic renal failure
• history of IBD
• participation other studies
• unsedated colonoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBB- Hioscine Butyl Bromide	Hyoscine Butyl Bromide 20mg/2 ml i.v.	-
Placebo arm	Saline 2 ml i.v.	-

Primary Outcome Measures

Name	Time	Method
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)	5 months

Secondary Outcome Measures

Name	Time	Method
Tolerability of HBB	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).

Trial Locations

Locations (1)

Ospedale Valduce; 🇮🇹 Como, Italy