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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.
Study performed in health subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geloprep | Experimental | Novel and patented Polyethylene glycol 3350 mixture |
|
| Moviprep | Active Comparator | Standard of care Polyethylene glycol 3350 mixture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A 06 ad | Drug | Colonic cleansing before colonoscopy and CT colonografi |
|
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel preparation scale (BBPscale) | 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. | Performed during the endoscopy procedure |
| Adverse events related to intervention | Any adverse event related to the intervention observed by investigators or as reported by the participant | Assessed 4 hours after last intake of cleansing product |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | mmHg systolic and diastolic measured on right or left arm. | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination |
| Saturation |
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Inclusion Criteria:
- Healthy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanne Holm, RN | Contact | +4593567014 | hanh@regionsjaelland.dk | |
| Svend Knuhtsen, MD | Contact | +4523348555 | svkn@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ismail Gögenur, Professor MD | Department of Surgery, Zealand University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuh | Køge | Region of Zealand | 4600 | Denmark |
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Oxymeter measuring the saturation of hemoglobin with oxygen as a percentage of 0-100%.
| Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination |
| Heart rate | Heart rate | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination |
| Respiration frequency | Respiration frequency | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination |