Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.

Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs split regimen (B) of Clensia, in patients undergoing endoscopy.

Enrolled patients, after providing written informed consent, are randomized to the CLENSIA preparation scheme, delayed full-dose or split-dose regimen. The delayed full-dose regimen will constitute study arm A while the split-dose regimen will constitute the control arm B.

Participants will follow a slag-free diet in the three days preceding the colonoscopy (reduction in the consumption of fruit, vegetables and legumes). On the day before the colonoscopy, patients will be able to have a normal breakfast and lunch that are both free of fiber. The dietary indications will be delivered in writing to the patient by the health staff of the center involved in the trial. From the moment the preparation begins with the intake of the product, the intake of solid foods will no longer be allowed while clear liquids of the patient's choice can be taken freely up to two hours before the colonoscopy.

The study ends for each patient with the execution of each procedure / examination planned for the visit 2 The effectiveness of the preparation in terms of intestinal cleansing is assessed blindly (by the endoscopist) using the scale (Boston Bowel Preparation Scale).

Inclusion Criteria:

• Male / female patients
• outpatient, consecutively subjected to colonoscopy with an exam scheduled from 8.00 to 10.00
• Age between 18 and 75 years
• Written informed consent

Exclusion Criteria:

• Hypersensitivity and contraindications to the product under study, to the active ingredients or to any of the excipients.

Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) <30 ml / min / 1.73 m2)

• Presence of known chronic inflammatory bowel disease
• Previous digestive tract surgery
• Suspected gastrointestinal perforation
• History of congestive heart failure (NYHA class III or IV)
• Severe hepatic insufficiency or impairment (in the case of Child-Pugh Class C accurate verification of the patient's condition) indicated by transaminase values greater than 3 times the maximum normal value.
• Toxic colitis or toxic megacolon
• Suspected intestinal obstruction
• Patients enrolled in colorectal cancer screening programs
• Intestinal paralysis
• Documented electrolyte disturbances (Na, Cl, K, Ca or P outside normal limits)
• Recent symptomatic acute ischemic heart disease (<6 months). Acute myocardial infarction and recent unstable angina within six months antecedents.
• Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug, whichever is longer.
• Documented state of pregnancy ascertained through positive pregnancy test