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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
321
Taking the colonoscopy preparation drug (Clensia) in a single administration
Taking the colonoscopy preparation drug (Clensia) in two stages of administration
Presidio Ospedaliero Sant'Ottone Frangipane
Ariano Irpino, Avellino, Italy
Reparto di Gastroenterologia IRRCS Saverio de Bellis
Castellana Grotte, BARI, Italy
SSD Endoscopia digestiva - Ospedale Manerbio
Manerbio, Brescia, Italy
Percentage of colonoscopies with adequate preparation
Percentage of colonoscopies with adequate preparation (according to BBPS score ≥ 2) in each colonic segment, in patient group A vs patient group B
Time frame: 1 day - the day of the colonoscopy
Quantity of bubbles
Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B
Time frame: 1 day - the day of the colonoscopy
tollerability and compliance
Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B
Time frame: 2 days - the day of the drug administration + the day of the colonoscopy
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SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara
Baggiovara, Modena, Italy
SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino
Belluno, Italy
Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola
Bologna, Italy
Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio
Crotone, Italy
Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II
Naples, Italy
S.S. Endoscopia Digestiva/ P.O. S. Jacopo
Pistoia, Italy
Chirurgia Generale AOU Policlinico Umberto I
Rome, Italy