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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colonic Adenomas
• Intervention / Treatment: Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.; Drug: Saline 2 ml i.v.

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emanuele Rondonotti, MD; Phone Number: 0039031324145; Email: ema.rondo@gmail.com

Study Locations

• Italy
  • Como, Italy, 20122
    • Recruiting
    • Ospedale Valduce
    • Contact: Spinzi Giancarlo, MD; Phone Number: 0039031324141; Email: gispinz@tin.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo arm	Drug: Saline 2 ml i.v.; Administration of Saline 2 ml at time of caecal intubation; Other Names: Saline
EXPERIMENTAL: HBB- Hioscine Butyl Bromide	Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.; Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation; Other Names: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Valduce Hospital
• Investigators: Study Director: Spinzi Giancarlo, MD, Gastroenterology Unit, Ospedale Valduce, Como, Italy.; Study Chair: Franco Radaelli, MD, Gastroenterology Unit, Ospedale Valduce, Como. Italy.; Principal Investigator: Emanuele Rondonotti, MD, Gastroenterology Unit, Ospedale Valduvce, Como. Italy.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2012
• Study Completion (ANTICIPATED): June 1, 2012

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Adenoma Detection Rate; Anti-spasmotic drug
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Anticonvulsants; Mydriatics; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: HBB-1