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The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.
Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994 gut lavage solution with 1 litre (or more) of extra clear liquids or 2 x 45 ml of a sodium phosphate solution plus 2 litres (or more) of extra clear liquids the day before colonoscopy. Patients requiring a morning colonoscopy who fulfil the inclusion criteria, will be randomised. One of the two tested products will be delivered by a pharmacist, blindly from the gastroenterologist. The assigned product will be taken the day before the coloscopy according to the information leaflet. Efficacy of the two tested preparations will be measured on video-tape record of each colonoscopy by a final grading i.e. "the overall quality of colonoscopy prep" by an gastroenterologist expert. A standardised patient questionnaire administered by a nurse on the morning before colonoscopy will assess clinical tolerance and acceptability (satisfaction) of the prep. A baseline blood sampling will be withdrew before intake of the preparation and one more blood sample will be performed after the intake on the morning, before the coloscopy.
After the coloscopy, as the gastroenterologist gives the result of the coloscopy , a last visit is performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1 pack (contains 4 (2 x PEG + E/"P" + 2 x Vitamin C/"C") sachets)= 2L NRL994 . 2 sachets (one of each) will be dissolved in 1L of water. Each litre will be drunk within 1 hour. Furthermore, at least 1000ml (or more) of any additional clear fluid (except milk) has to be drunk after the 2L of NRL994. |
|
| 2 | Active Comparator | 1 pack consists of 2 flasks of 45ml. Each flask has to be dissolved within 125ml of water. Each intake of NaP solution has to be preceded and followed by 250ml (or more if necessary)of clear liquids(excluding milk)and a delay of at least 12 hours between the intake of the 2 x 45ml of NaP solution has to be completed. In addition, 750ml more of clear liquids (excluding milk)or more if needed must be drunk between the 2 intakes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate | Drug | 2L gut lavage solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy will be measured and graded using video-taped record of each colonoscopy for cleansing in a 0 - 4 grade scale for each of the predefined colon areas by an endoscopist. | ||
| Grades A or B means a good or correct preparation and are considered as a success whilst C or D are considered as a failed preparation. |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of the preparation quality using a visual analogue scale | ||
| recording adverse events and clinical tolerance | ||
| patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Bitoun, MD | Hôpital Lariboisère | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jean Minjoz | Besançon | 25030 | France | |||
| Hôpital Mourier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2293568 | Background | Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6. doi: 10.1016/0016-5085(90)91284-d. |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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| Sodium Phosphate Solution | Drug | 1 x 45ml solution, BID |
|
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| Colombes |
| 92700 |
| France |
| Hôpital Huriez | Lille | 59037 | France |
| Hôpital Dupuytren | Limoges | 87000 | France |
| Hôpital Edouard Herriot | Lyon | 69003 | France |
| Hôpital Nord | Marseille Nord Cedex 20 | 13915 | France |
| Centre Hospitalier | Montélimar | 26216 | France |
| Centre Hospitalier Intercommunal | Montfermeil | 93370 | France |
| Centre Hospitalier De Montpellier Hôpital St Eloi | Montpellier | 34000 | France |
| Hôpital De L'Archet | Nice | 06202 | France |
| Hôpital Bichat Claude Bernard | Paris | 75018 | France |
| Hôpital Croix Saint Simon | Paris | 75020 | France |
| Hôpital Cochin | Paris | 75379 | France |
| Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré | Paris | 75475 | France |
| Hôpital Civil / Clinique Medical B | Strasbourg | 67091 | France |
| Hôpital Rangueil | Toulouse | 31403 | France |
| Hôpital Trousseau CHRU | Tours | 37000 | France |
| CHU De Brabois | Vandœuvre-lès-Nancy | 54511 | France |