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Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clensia® | Experimental | Clensia®, powder for oral solution in sachet. To be taken in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination. |
|
| Citrafleet® | Experimental | Citrafleet®, powder for oral solution in sachet. To be taken in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clensia® | Drug | Participants will take the treatment in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)). | week 2 (Colonoscopy visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion detection rate | Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group. | week 2 (Colonoscopy visit) |
| Adenomas per colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Pellisé | Contact | +34 932275400 | MPELLISE@clinic.cat | |
| Judit Pich | Contact | +34 932275400 | 2815 | JPICH@recerca.clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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blind endoscopist, unblinded nurse and patient
| Citrafleet® | Drug | Participants will take the treatment in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination. |
|
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
| week 2 (Colonoscopy visit) |
| Presence of foam | The presence of foam using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing). | week 2 (Colonoscopy visit) |
| Presence of bubbles | The presence of bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing). | week 2 (Colonoscopy visit) |
| Quality of colon cleansing | The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate. | week 2 (Colonoscopy visit) |
| Need for washing tools during colonoscopy | Need for washing tools during colonoscopy. The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted. Likewise, the volume of simethicone used will be counted if it is considered necessary. | week 2 (Colonoscopy visit) |
| Cecal intubation rate | Cecal intubation rate. The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete. | week 2 (Colonoscopy visit) |
| Cecal intubation time | Cecal intubation time. Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus. | week 2 (Colonoscopy visit) |
| Endoscope removal time | Endoscope removal time. Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions. | week 2 (Colonoscopy visit) |
| Requires repeat colonoscopy due to poor preparation | Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale | week 2 (Colonoscopy visit) |
| Adherence to the intake of the preparation | Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Tolerability and satisfaction questionnaire). | week 2 (Colonoscopy visit) |
| Ease of taking the preparation | Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire). | week 2 (Colonoscopy visit) |
| Palatability of the preparation | Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire). | week 2 (Colonoscopy visit) |
| Willingness to repeat the intake of the preparation | Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire). | week 2 (Colonoscopy visit) |
| Overall satisfaction with the intake of the preparation | Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Tolerability and satisfaction questionnaire). | week 2 (Colonoscopy visit) |
| Endoscopist's satisfaction with the cleaning of faecal remains and bubbles | Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Data collection form). | week 2 (Colonoscopy visit) |
| Rate of adverse events | Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Tolerability and Satisfaction Questionnaire). | week 2 (Colonoscopy visit) and week 4 (visit 2) |