Pharmacological Action
Conditions
Brief summary
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy
Detailed description
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy. Study performed in health subjects.
Interventions
DRUGA 06 ad
Colonic cleansing before colonoscopy and CT colonografi
Sponsors
University of Copenhagen
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy
Exclusion criteria
* Allergy to content of products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel preparation scale (BBPscale) | Performed during the endoscopy procedure | Visual assessment of the degree of bowel cleansing performed by the endoscopist (blinded). Right colon, colon transversum, and left colon are each judged on a scale from 0-3 with higher scores indicating better cleansing. Range of score between 0-9. |
| Adverse events related to intervention | Assessed 4 hours after last intake of cleansing product | Any adverse event related to the intervention observed by investigators or as reported by the participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination | mmHg systolic and diastolic measured on right or left arm. |
| Saturation | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination | Oxymeter measuring the saturation of hemoglobin with oxygen as a percentage of 0-100%. |
| Heart rate | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination | Heart rate |
| Respiration frequency | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination | Respiration frequency |
Countries
Denmark
Contacts
Primary ContactHanne Holm, RN
Backup ContactSvend Knuhtsen, MD
Outcome results
None listed