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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Emanuele Rondonotti, Valduce Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609855
First Posted: June 1, 2012
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emanuele Rondonotti, Valduce Hospital
  Purpose
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.

Condition Intervention Phase
Colonic Adenomas Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v. Drug: Saline 2 ml i.v. Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Emanuele Rondonotti, Valduce Hospital:

Primary Outcome Measures:
  • Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) [ Time Frame: 5 months ]

Secondary Outcome Measures:
  • Tolerability of HBB [ Time Frame: this outcome will be evaluated at the end of colonoscopy ]
    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).


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.
Placebo Comparator: Placebo arm Drug: Saline 2 ml i.v.
Administration of Saline 2 ml at time of caecal intubation
Other Name: Saline

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609855


Contacts
Contact: Emanuele Rondonotti, MD 0039031324145 ema.rondo@gmail.com

Locations
Italy
Ospedale Valduce Recruiting
Como, Italy, 20122
Sub-Investigator: Gianni Imperiali, MD         
Principal Investigator: Vittorio Terruzzi, MD         
Sub-Investigator: Giovanna Mandelli, MD         
Sub-Investigator: Silvia Paggi, MD         
Sub-Investigator: Nicoletta Lenoci, MD         
Sub-Investigator: Arnaldo Amato, MD         
Sub-Investigator: Natalia Terreni, MD         
Ospedale Valduce Recruiting
Como, Italy, 20122
Contact: Spinzi Giancarlo, MD    0039031324141    gispinz@tin.it   
Sponsors and Collaborators
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.
  More Information

Responsible Party: Emanuele Rondonotti, Principal investigator, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01609855     History of Changes
Other Study ID Numbers: HBB-1
First Submitted: May 7, 2012
First Posted: June 1, 2012
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Emanuele Rondonotti, Valduce Hospital:
Adenoma Detection Rate
Anti-spasmotic drug

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bromides
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Anticonvulsants
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics