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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000587-10 | Registry Identifier | EudraCT |
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The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG | Active Comparator | polyethylene glycol solution 2 liters |
|
| NapP | Active Comparator | Sodium picosulphate and magnesium citrate solution 300 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethylene glycole (PEG) solution | Drug |
| ||
| sodium picosulphate and magnesium citrate solution |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale value | evaluated by two endoscopists who are blinded to treatment assigned at randomization | at time of colonscopy |
| patient reported acceptability score | using visual analog scale | just prior to colonscopy |
| Measure | Description | Time Frame |
|---|---|---|
| percent of bowel cleansing regimen dose assumed as reported by patient | just prior to colonoscopy |
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Inclusion Criteria:
• Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valentina D'Angelo, M.D. | National Cancer Institute, Naples | Principal Investigator |
| Mario de Bellis, M.D. | National Cancer Institute, Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidio Ospedaliero Villa d'Agri | Marsicovetere | Italy | ||||
| AO Fatebenefratelli ed Oftalmico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36569131 | Derived | D'Angelo V, Piccirillo MC, Di Maio M, Gallo C, Bucci C, Civiletti C, Di Girolamo E, Marone P, Rossi GB, Tempesta AM, Tracey MC, Romano M, Miranda A, Taranto D, Sessa G, Esposito P, Salerno R, Pumpo R, De Filippo FR, Della Valle E, de Bellis M, Perrone F. A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial. Front Med (Lausanne). 2022 Dec 8;9:1013804. doi: 10.3389/fmed.2022.1013804. eCollection 2022. |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| C005701 | picosulfate sodium |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
| Milan |
| Italy |
| A.O.U. Seconda Universita di Napoli | Naples | Italy |
| Clinica Mediterranea | Naples | Italy |
| Istituto Nazionale dei Tumori | Naples | Italy |
| Presidio Ospedaliero Ascalesi | Naples | Italy |
| Presidio Ospedaliero Maresca | Torre del Greco | Italy |