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

Colonic Adenomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01609855
• Other study ID #: HBB-1
• Status: Recruiting
• Phase: Phase 4
• First received: May 7, 2012
• Last updated: May 31, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2012
• Source: Valduce Hospital
• Contact: Emanuele Rondonotti, MD
• Phone: 0039031324145
• Email: ema.rondo[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenomas

Intervention

Drug:
• Hyoscine Butyl Bromide 20mg/2 ml i.v.
Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation
• Saline 2 ml i.v.
Administration of Saline 2 ml at time of caecal intubation

Locations

Country	Name	City	State
Italy	Ospedale Valduce	Como
Italy	Ospedale Valduce	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)		5 months	No
Secondary	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).	this outcome will be evaluated at the end of colonoscopy	No