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It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2L PEG-CS plus bisacodyl | Experimental | Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit) |
|
| 2L PEG-ASC | Active Comparator | Patients will be asked to take PEG-ASC according to labeling instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2L PEG-CS plus bisacodyl | Drug | Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the quality of bowel preparation by BBPS | BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mucosal visibility between the two groups | Three point rating scale(0-2). | 20 minutes |
| Number of patients with adverse events | Patient questioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, MD | IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy | Principal Investigator |
| Renzo Cestari, Prof. MD | Spedali Civili di Brescia, Brescia - Italy | Principal Investigator |
| Cesare Hassan, MD | Nuovo Regina Margherita, Roma - Italy | Principal Investigator |
| Angelo Andriulli, MD | IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - Italy | Principal Investigator |
| Vito Annese, MD | Ospedale Careggi, Firenze - Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy | ||
| IRCCS Humanitas |
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| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| C520497 | MoviPrep |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| 2L PEG-ASC | Drug | Patients will asked to take PEG-ASC according to labeling instructions |
|
|
| 24 hours |
| Difference in tolerability between the two groups | Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation. | 24 hours |
| Difference in patients acceptability between the two groups | Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation. | 24 hours |
| Difference in patients compliance between the two groups | Difference in the percentage of patients who took at least 75% of bowel preparation. | 24 hours |
| Rozzano |
| Milano |
| 20089 |
| Italy |
| Spedali Civili | Brescia | 25123 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50134 | Italy |
| Nuovo Regina Margherita | Roma | 00185 | Italy |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |