Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?
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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 |
- Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Emanuele Rondonotti, MD | 0039031324145 | ema.rondo@gmail.com |
| 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 | |
| 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, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Bromides Scopolamine Butylscopolammonium Bromide Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Mydriatics Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on May 23, 2013