Condition category
Digestive System
Date applied
03/11/2010
Date assigned
17/11/2010
Last edited
15/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank ter Borg

ORCID ID

Contact details

Department of Gastroenterology and Hepatology
Deventer Ziekenhuis
Nico Bolkesteinlaan 75
Deventer
7416 SE
Netherlands
+31 (0)570 535147
ftb@online.nl

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 form
2. Insurance coverage explanation
3. Contact addresses of investigator and independent consultant
4. 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 measures

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

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

http://www.dz.nl

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22317882

Publication citations

  1. 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.

Additional files

Editorial Notes