The use of bowel relaxant Buscopan® to improve the detection of colonic polyps during colonoscopy

ISRCTN	ISRCTN25405865
DOI	https://doi.org/10.1186/ISRCTN25405865
Protocol serial number	BUSCOPAN_PDR1
Sponsor	Deventer Hospital (Netherlands)
Funder	Deventer Hospital (Netherlands)

Submission date: 03/11/2010
Registration date: 17/11/2010
Last edited: 22/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Frank ter Borg
Scientific

Department of Gastroenterology and Hepatology
Deventer Ziekenhuis
Nico Bolkesteinlaan 75
Deventer
7416 SE
Netherlands

Study information

Primary study design	Interventional
Study design	Prospective double blind randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The influence of hyoscine N-butylbromide on the colonoscopic polyp detection: A prospective, double blind, randomised, placebo-controlled trial
Study objectives	To investigate whether the administration of Buscopan® will improve the detection, removal and harvesting of colonic polyps during colonoscopy.
Ethics approval(s)	Submission to the Medical Ethics Committee at Isala Klinieken, Zwolle, The Netherlands expected by the end of November 2010
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hyoscine N-butylbromide (Buscopan®)
Primary outcome measure(s)	The number of colonoscopies during which at least one polyp has been found divided by the total number of colonoscopies
Key secondary outcome measure(s)	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
Completion date	15/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	672
Key inclusion criteria	1. Patients aged 30 years or older 2. Able to understand and give informed consent 3. Routinely referred for colonoscopy
Key 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
Date of first enrolment	15/01/2010
Date of final enrolment	15/01/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Gastroenterology and Hepatology

Deventer
7416 SE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/03/2019: Internal review.
21/03/2019: Internal review.