Clinical trial NCT05570669: Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.
Official title: Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Societa Italiana di Endoscopia Digestiva
Sponsor class: OTHER
Collaborators: name: Presidio Ospedaliero Sant Ottone Frangipane Avellino
name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
name: Azienda Policlinico Umberto I
name: Ospedale di Manerbio ASST Garda
name: Ospedale Civile San Giovanni di Dio Crotone
name: Ospedale di Baggiovara Modena
name: Ospedale S. Jacopo Pistoia
name: Ospedale S. Martino Belluno
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Federico II University
First posted: 2022-10-06
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups randomized 1:1
Primary purpose: SCREENING

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of colonoscopies with adequate preparation
timeFrame: 1 day - the day of the colonoscopy
Secondary outcomes:
measure: Quantity of bubbles
timeFrame: 1 day - the day of the colonoscopy
measure: tollerability and compliance
timeFrame: 2 days - the day of the drug administration + the day of the colonoscopy
Other outcomes:
Locations:
city: Ariano Irpino
country: Italy
facility: Presidio Ospedaliero Sant'Ottone Frangipane
state: Avellino
city: Castellana Grotte
country: Italy
facility: Reparto di Gastroenterologia IRRCS Saverio de Bellis
state: Bari
city: Manerbio
country: Italy
facility: SSD Endoscopia digestiva - Ospedale Manerbio
state: Brescia
city: Baggiovara
country: Italy
facility: SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara
state: Modena
city: Belluno
country: Italy
facility: SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino
city: Bologna
country: Italy
facility: Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola
city: Crotone
country: Italy
facility: Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio
city: Napoli
country: Italy
facility: Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II
city: Pistoia
country: Italy
facility: S.S. Endoscopia Digestiva/ P.O. S. Jacopo
city: Rome
country: Italy
facility: Chirurgia Generale AOU Policlinico Umberto I
Study officials:
affiliation: Societa Italiana di Endoscopia Digestiva
name: LUIGI PASQUALE, PROF
role: STUDY_CHAIR
References: