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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01609855
Enrollment
400
Registered
2012-06-01
Start date
2012-01-31
Completion date
2012-06-30
Last updated
2012-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Adenomas

Keywords

Adenoma Detection Rate, Anti-spasmotic drug

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).

Interventions

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

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

DRUGSaline 2 ml i.v.

Administration of Saline 2 ml at time of caecal intubation

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)5 months

Secondary

MeasureTime frameDescription
Tolerability of HBBthis outcome will be evaluated at the end of colonoscopyAs 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).

Countries

Italy

Contacts

Primary ContactEmanuele Rondonotti, MD
ema.rondo@gmail.com0039031324145

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026