A Phase 4 interventional study of (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose and (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose in Colonoscopy, sponsored by Societa Italiana di Endoscopia Digestiva. Completed at 10 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by Societa Italiana di Endoscopia Digestiva · Phase 4, Interventional, and Screening
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).
This is the only study on the registry with Societa Italiana di Endoscopia Digestiva as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) \<30 ml / min / 1.73 m2)
Group A "delayed full-dose" regimen (study arm): intake of two large A sachets and 2 small B sachets from 20:30 to 22:00 the evening before the exam. Taking the remaining 2 envelopes A large e 2 small B envelopes from 10.30 pm to midnight the evening before the exam.
Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose
Group B "split-dose" regimen (control arm): intake of two large A sachets and two small B sachets from 20.30 to 22:00 the evening before the exam. The remaining two large A envelopes and two small B envelopes will be taken 5 hours earlier than the time when the exam is scheduled on the same day as the exam.
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 a single administration
Also known as: Clensia in full dose
Taking the colonoscopy preparation drug (Clensia) in two stages of administration
Also known as: Clensia in Split dose
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
Plan to share: Yes — THE STUDY IS PROMOTED BY THE ITALIAN SOCIETY OF DIGESIVE ENDOSCOPY as part of research activities for the improvement of clinical practices
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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