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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Valduce Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Emanuele Rondonotti, Valduce Hospital
ClinicalTrials.gov Identifier:
NCT01609855
First received: May 7, 2012
Last updated: May 31, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 Valduce Hospital:

Primary Outcome Measures:
  • Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of HBB [ Time Frame: this outcome will be evaluated at the end of colonoscopy ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Emanuele Rondonotti, Principal investigator, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01609855     History of Changes
Other Study ID Numbers: HBB-1
Study First Received: May 7, 2012
Last Updated: May 31, 2012
Health Authority: Italy: The Italian Medicines Agency
Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014