NCT05570669

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Societa Italiana di Endoscopia Digestiva · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Colonoscopy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-25
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2022-10-06
• Last updated: 2022-10-06

Locations

10 sites across 1 country: Italy