Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BUSCOPAN_PDR1
Study information
Scientific title
The influence of hyoscine N-butylbromide on the colonoscopic polyp detection: A prospective, double blind, randomised, placebo-controlled trial
Acronym
Study hypothesis
To investigate whether the administration of Buscopan® will improve the detection, removal and harvesting of colonic polyps during colonoscopy.
Ethics approval
Submission to the Medical Ethics Committee at Isala Klinieken, Zwolle, The Netherlands expected by the end of November 2010
Study design
Prospective double blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
1. Patient information form2. Insurance coverage explanation3. Contact addresses of investigator and independent consultant4. Signature form
Condition
Colonoscopy; Colonic polyp; Colorectal carcinoma
Intervention
Intravenous administration of Buscopan or 0.9% Natriumchloride Solutution (placebo) during colonoscopy.
No further interventions
The duration of the action of Buscopan is only 20 minutes, and in this time colonoscopy will be finished. Data on polyp removal etc will be recorded during colonoscopy. There will be no further follow up, but participants will be informed about the histology of removed polyps in the outpatient department, as per usual practice.
Intervention type
Drug
Phase
Not Applicable
Drug names
Hyoscine N-butylbromide (Buscopan®)
Primary outcome measure
The number of colonoscopies during which at least one polyp has been found divided by the total number of colonoscopies
Secondary outcome measures
1. Polyp detection score
During each colonoscopy the number and shape of the polyps will be recorded.
Polyps < 5 mm will confer 3 points
Polyps 5-10 mm will confer 2 points
Polyps > 10 mm will confer 1 point
Scores will be made for flat / broad based polyps as well as rounded / pedunculated polyps.
2. Polyp removal ratio
The number of removed polyps divided by the number of detected polyps
3 Pathology retrieval ratio
The number of polyps send for pathological investigation divided by the number of removed polyps
4 Influence of age category
Categories are: 30 - 50 years, 51 70 years and > 70 years.
5 Influence of diverticulosis category
Categories are: 1: 0-2 diverticula, 2: 3-10 diverticula, 3: 11-20 diverticula en 4: > 20 diverticula.
6 Influence of the endocopist
Overall trial start date
15/01/2010
Overall trial end date
15/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 30 years or older
2. Able to understand and give informed consent
3. Routinely referred for colonoscopy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
672
Participant exclusion criteria
1. Pregnancy
2. Myasthenia gravis
3. Exacerbation of inflammatory bowel disease
4. Suspicion of ongoing diverticulitis
5. Expectation of an estimated probability of complete colonoscopy of less than 50%, e.g. by the presence of a stenosis
Recruitment start date
15/01/2010
Recruitment end date
15/01/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Gastroenterology and Hepatology
Deventer
7416 SE
Netherlands
Sponsor information
Organisation
Deventer Hospital (Netherlands)
Sponsor details
Nico Bolkesteinlaan 75
Deventer
7416 SE
Netherlands
+31 (0)570 535147
Borgtf@dz.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Deventer Hospital (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22317882
Publication citations
-
Results
de Brouwer EJ, Arbouw ME, van der Zwet WC, van Herwaarden MA, Ledeboer M, Jansman FG, ter Borg F, Hyoscine N-butylbromide does not improve polyp detection during colonoscopy: a double-blind, randomized, placebo-controlled, clinical trial., Gastrointest. Endosc., 2012, 75, 4, 835-840, doi: 10.1016/j.gie.2011.12.010.