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| ID | Type | Description | Link |
|---|---|---|---|
| 02/2000 |
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Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.
Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas. |
| Measure | Description | Time Frame |
|---|---|---|
| Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0). | ||
| Amount of fluid removed from the colon during the colonoscopy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Bitoun, MD | Hopital Lariboisière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lariboisière, Endoscopy Department | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7380204 | Background | Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5. |
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