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.
Study Type
OBSERVATIONAL
Enrollment
601
bowel preparation product for colonoscopy as part of CRC screening
Clinique des Cèdres, Ramsay Santé,
Cornebarrieu, France
Polyclinique Louis Pasteur,
Essey-lès-Nancy, France
Saint Joseph Hospital
Marseille, France
5. Clinique Ambroise Paré
Toulouse, France
Pole Santé des Haberges
Vesoul, France
Assess the quality of the bowel preparation assessed by Bubble scale
Time frame: During procedure
Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)
Time frame: During procedure
Colonoscope removal time
time spent by the endoscopist searching for polyps and adenomas (mn)
Time frame: immediately post procedure
The frequency of adverse events (AEs)
including nausea, vomiting, abdominal bloating - and their severity,
Time frame: within 10 minutes post procedure
volume of bowel preparation ingested
in ml
Time frame: immediately post procedure
Caecal intubation rate
successful Caecal intubation
Time frame: immediately post procedure.
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