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This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard approach | Active Comparator | patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic:
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| Individualized approach | Experimental | patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard approach | Drug | bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| bowel cleansing | bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| patient comfort level during bowel cleansing | patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodor Voiosu, MD, PhD | Clinical Hospital Colentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colentina Clinical Hospital | Bucharest | 020125 | Romania | |||
| Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23799210 | Background | Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34. |
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| Individualized approach | Drug |
|
|
| Cluj-Napoca |
| Romania |
| Spitalul CFR | Cluj-Napoca | Romania |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| C005701 | picosulfate sodium |
| C110422 | magnesium citrate |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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