The use of bowel relaxant Buscopan® to improve the detection of colonic polyps during colonoscopy
| ISRCTN | ISRCTN25405865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25405865 |
| Secondary identifying numbers | BUSCOPAN_PDR1 |
- 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
Scientific
Department of Gastroenterology and Hepatology
Deventer Ziekenhuis
Nico Bolkesteinlaan 75
Deventer
7416 SE
Netherlands
Study information
| Study design | Prospective double blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | 1. Patient information form2. Insurance coverage explanation3. Contact addresses of investigator and independent consultant4. Signature form |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/01/2010 |
| Completion date | 15/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
7416 SE
Netherlands
Sponsor information
Deventer Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Nico Bolkesteinlaan 75
Deventer
7416 SE
Netherlands
| Phone | +31 (0)570 535147 |
|---|---|
| Borgtf@dz.nl | |
| Website | http://www.dz.nl |
"ROR" |
https://ror.org/05w8df681 |
Funders
Funder type
Hospital/treatment centre
Deventer Hospital (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
22/03/2019: Internal review.
21/03/2019: Internal review.
