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| Name | Class |
|---|---|
| Norgine BV | UNKNOWN |
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Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenient diet | Experimental | This group can have a less stringent diet compared to the current standard of care and eat a light meal until 18h before drinking the first dose of the bowel preparation on the day before the colonoscopy |
|
| Control group | No Intervention | This group follows the strict diet similar to what is currently used in standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenient diet | Behavioral | The interventional goup receives the lenient diet instructions and will eat a light meal until 18h on the day before the colonoscopy. The first dose of Plenvu will be started at 20h. All the other bowel preparation instructions will be the same as in the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1) | Max 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with an optimal bowel preparation (BBPS 8-9) | Max 12 weeks | |
| Detection rates | Adenoma Detection Rate (ADR), Polyp Detection Rate (PDR), Serrated Polyp Detection Rate (SPDR), Advanced Adenoma Detection Rate (aADR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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The endoscopist who performs the colonoscopy and the investigator who acts as second observer are blinded to objectively assess the BBPS.
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| Max 12 weeks |
| Number of patients with high-quality right sided colon preparation (subscore = 3) | Max 12 weeks |
| Overall patient's tolerance, adherence and satisfaction based on the patient's diary | Max 12 weeks |