Efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy: a randomized parallel comparative trial. CLEAN+

Prior treatment

• Partial or total colon resection.

Other illness

• Severe renal failure (grade IV or V) (Annex 5, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 6, NYHA Scale).
• Hypersensitivity to the active ingredients of excipients.
• 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).
• Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease).
• Terminal illness or serious illness/disability that contraindicates subsequent colon study.
• Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).

Lab values

• Glucose-6-phosphate dehydrogenase deficiency.

Other

• Hypermagnesemia.
• Rhabdomyolysis.
• Phenylketonuria.
• Pregnancy or breastfeeding.
• Colonoscopy within the last year.
• Barthel Index of <20 (Annex 4, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 7, Rome IV Criteria).
• Do not understand spoken or written Catalan or Spanish.

• Men and women aged 49 to 70.
• 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.
• Signed informed consent form.