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To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2L gut cleansing solution |
|
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate | Drug | 2L gut lavage solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure"). |
| Measure | Description | Time Frame |
|---|---|---|
| the "overall" judgment of the investigator for the colon preparation was documented. | ||
| Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Ell, Prof Dr med | Dr. Horst Schmidt Kliniken GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Aschaffenburg Am Hasenkopf 1 | Aschaffenburg | Bavaria | 63739 | Germany | ||
| Schiessgrabenstr. 34 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ell C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 38 (Suppl II): A18 | ||
| 25180609 | Derived | Ell C, Fischbach W, Layer P, Halphen M. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin. 2014 Dec;30(12):2493-503. doi: 10.1185/03007995.2014.960513. Epub 2014 Sep 23. |
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| Sodium Phosphate solution (NaP) | Drug | 45 ml solution; BID |
|
| The taste of the solutions was assessed. |
| Acceptability and tolerance for the subject was compared. |
| All Adverse Events were recorded to evaluate the safety. |
| Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance. |
| Augsburg |
| Bavaria |
| 86150 |
| Germany |
| Spardorfer Str. 39 | Erlangen | Bavaria | 91054 | Germany |
| Heiligengrabstr. 22 | Hof | Bavaria | 95028 | Germany |
| Rätestr. 20 | Kirchheim | Bavaria | 85551 | Germany |
| Sternbergstr. 8 | Regensburg | Bavaria | 93047 | Germany |
| Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14 | Hamburg | Free and Hanseatic City of Hamburg | 22297 | Germany |
| Dieburger Str. 29 | Darmstadt | Hesse | 64287 | Germany |
| Unter den Eichen 26 | Oldenburg | Lower Saxony | 26122 | Germany |
| Erzbergstr. 113 | Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72 | Erfurt | Thuringia | 99097 | Germany |
| Uferstr. 3 | Minden | Westfalen-Lippe | 32423 | Germany |
| ID | Term |
|---|---|
| C520497 | MoviPrep |
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