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To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CitraFleet | Active Comparator | Administration of CitraFleet |
|
| MOVIPREP | Experimental | Administration of MOVIPREP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOVIPREP | Drug |
| ||
| CitraFleet |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp detection rate | Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist | At colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate (ADR) | ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population | At the Colonoscopy |
| ADR and PDR by location |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Fishbach, MD | Klinikum Aschaffenburg-Alzenau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Aschaffenburg | Aschaffenburg | Am Hasenkopf 1 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25950434 | Derived | Pohl J, Halphen M, Kloess HR, Fischbach W. Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study. PLoS One. 2015 May 7;10(5):e0126067. doi: 10.1371/journal.pone.0126067. eCollection 2015. |
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|
ADR and PDR by location:
| at the colonoscopy |
| Cancer detection rate | Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population | at the colonoscopy |
| Flat lesion only detection rate | Flat lesion only detection of the patients | at the colonoscopy |
| Advanced risk lesion detection rate | Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous | at the colonoscopy |
| Colonoscopy completion rate | The rate of colonoscopy completion | at the colonoscopy |
| Colon cleansing quality | Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale© | at the colonoscopy |
| Acceptability and tolerability of medication using patient questionnaires | The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires | Throughout the study |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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