NCT06319924

Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy

Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy: Phase 4 Prospective Multicenter Real Life Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 601 (actual)
• Sponsor: Hospital St. Joseph, Marseille, France · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: —

Summary

Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation. Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments.

Conditions

• Colorectal Cancer
• Colonoscopy
• Bowel Preparation Solution

Interventions

Type	Name	Description
DRUG	Simethicone combined with Macrogol 4000 (PEG)	bowel preparation product for colonoscopy as part of CRC screening

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-05-31
• Completion: 2022-09-15
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

5 sites across 1 country: France