Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Men and women aged 50 to 69.
Have participated in the early detection program for colorectal cancer.
Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale).
Colonoscopy within the last year.
Barthel Index of <20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria).
Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders).
Parallel
Clensia®
DrugParticipants 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.
Citrafleet®
DrugParticipants 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.
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)).
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.
Adenomas per colonoscopy
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
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).
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).
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