(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose
DrugTaking the colonoscopy preparation drug (Clensia) in a single administration
Other names: Clensia in full dose
NCT Number: NCT05570669
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Presidio Ospedaliero Sant'Ottone Frangipane, Ariano Irpino, Avellino, Italy
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) <30 ml / min / 1.73 m2)
Taking the colonoscopy preparation drug (Clensia) in a single administration
Other names: Clensia in full dose
Taking the colonoscopy preparation drug (Clensia) in two stages of administration
Other names: Clensia in Split dose
Time frame: 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
Time frame: 1 day - the day of the colonoscopy
Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B
Time frame: 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
Societa Italiana di Endoscopia Digestiva
Other
Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.
Acronym: ERACLES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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