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

NCT ID: NCT01609855

Last Updated: 2012-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-06-30

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).

Conditions

Colonic Adenomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

HBB- Hioscine Butyl Bromide

Group Type: EXPERIMENTAL

Hyoscine Butyl Bromide 20mg/2 ml i.v.

Intervention Type: DRUG

Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation

Placebo arm

Group Type: PLACEBO_COMPARATOR

Saline 2 ml i.v.

Intervention Type: DRUG

Administration of Saline 2 ml at time of caecal intubation

Interventions

Hyoscine Butyl Bromide 20mg/2 ml i.v.

Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation

Intervention Type: DRUG

Saline 2 ml i.v.

Administration of Saline 2 ml at time of caecal intubation

Intervention Type: DRUG

Other Intervention Names

Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.; Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valduce Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emanuele Rondonotti

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Spinzi Giancarlo, MD

Role: STUDY_DIRECTOR

Gastroenterology Unit, Ospedale Valduce, Como, Italy.

Franco Radaelli, MD

Role: STUDY_CHAIR

Gastroenterology Unit, Ospedale Valduce, Como. Italy.

Emanuele Rondonotti, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Unit, Ospedale Valduvce, Como. Italy.

Locations

Ospedale Valduce

Como, , Italy

Site Status: RECRUITING

Ospedale Valduce

Como, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Emanuele Rondonotti, MD

Role: CONTACT

ema.rondo@gmail.com

0039031324145

Facility Contacts

Spinzi Giancarlo, MD

Role: primary

gispinz@tin.it

0039031324141

Other Identifiers

HBB-1

Identifier Type: -

Identifier Source: org_study_id