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

Primary Purpose

Colonic Adenomas

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

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

Saline 2 ml i.v.

Sponsored by

Valduce Hospital

About this trial

This is an interventional diagnostic trial for Colonic Adenomas focused on measuring Adenoma Detection Rate, Anti-spasmotic drug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ospedale ValduceRecruiting
Ospedale ValduceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HBB- Hioscine Butyl Bromide

Placebo arm

Arm Description

Outcomes

Primary Outcome Measures

Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)

Secondary Outcome Measures

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).

Full Information

NCT ID

First Posted

May 7, 2012

Last Updated

May 31, 2012

Sponsor

Valduce Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01609855

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Valduce Hospital

4. Oversight

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Adenomas

Keywords

Adenoma Detection Rate, Anti-spasmotic drug

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HBB- Hioscine Butyl Bromide

Arm Type

Experimental

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline 2 ml i.v.

Other Intervention Name(s)

Saline

Intervention Description

Administration of Saline 2 ml at time of caecal intubation

Primary Outcome Measure Information:

Title

Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Tolerability of HBB

Description

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).

Time Frame

this outcome will be evaluated at the end of colonoscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emanuele Rondonotti, MD

Phone

0039031324145

Email

ema.rondo@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Spinzi Giancarlo, MD

Organizational Affiliation

Gastroenterology Unit, Ospedale Valduce, Como, Italy.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Franco Radaelli, MD

Organizational Affiliation

Gastroenterology Unit, Ospedale Valduce, Como. Italy.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Emanuele Rondonotti, MD

Organizational Affiliation

Gastroenterology Unit, Ospedale Valduvce, Como. Italy.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale Valduce

City

Como

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gianni Imperiali, MD

First Name & Middle Initial & Last Name & Degree

Vittorio Terruzzi, MD

First Name & Middle Initial & Last Name & Degree

Giovanna Mandelli, MD

First Name & Middle Initial & Last Name & Degree

Silvia Paggi, MD

First Name & Middle Initial & Last Name & Degree

Nicoletta Lenoci, MD

First Name & Middle Initial & Last Name & Degree

Arnaldo Amato, MD

First Name & Middle Initial & Last Name & Degree

Natalia Terreni, MD

Facility Name

Ospedale Valduce

City

Como

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Spinzi Giancarlo, MD

Phone

0039031324141

Email

gispinz@tin.it

12. IPD Sharing Statement

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

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