Colonoscopy
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUG(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose
Taking the colonoscopy preparation drug (Clensia) in a single administration
DRUG(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose
Taking the colonoscopy preparation drug (Clensia) in two stages of administration
Sponsors
Presidio Ospedaliero Sant Ottone Frangipane Avellino
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Azienda Policlinico Umberto I
Ospedale di Manerbio ASST Garda
Ospedale Civile San Giovanni di Dio Crotone
Ospedale di Baggiovara Modena
Ospedale S. Jacopo Pistoia
Ospedale S. Martino Belluno
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Federico II University
Societa Italiana di Endoscopia Digestiva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
the endoscopist analyzes the results and evaluates the cleaning without knowing the treatment followed by the patient
Intervention model description
two groups randomized 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of colonoscopies with adequate preparation | 1 day - the day of the colonoscopy | Percentage of colonoscopies with adequate preparation (according to BBPS score ≥ 2) in each colonic segment, in patient group A vs patient group B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of bubbles | 1 day - the day of the colonoscopy | Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B |
| tollerability and compliance | 2 days - the day of the drug administration + the day of the colonoscopy | Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B |
Countries
Italy
Outcome results
None listed