Bowel Preparation Solution, Colonoscopy, Colorectal Cancer
Conditions
Brief 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.
Interventions
DRUGSimethicone combined with Macrogol 4000 (PEG)
bowel preparation product for colonoscopy as part of CRC screening
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Inclusion criteria
patients : * scheduled for colonoscopy as part of CRC screening, using the bowel preparation with fixed low-dose of simethicone combined with Macrogol 4000 (PEG) * aged 50-75 years, * with no family history of CRC or personal history of colon polyps but with a positive Faecal Immunochemical Test (FIT), with a family history of CRC or personal history of colon polyps, * requiring surveillance colonoscopy after 5 years if diagnosed with one or two tubular adenomas \<10 mm in diameter (low-risk group) or after 3 years if diagnosed with at least 3 adenomas or any adenoma at least 10 mm in diameter or with high-grade dysplasia, according to French recommendations during the study inclusion period.
Exclusion criteria
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Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the quality of the bowel preparation assessed by Bubble scale | During procedure |
| Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS) | During procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colonoscope removal time | immediately post procedure | time spent by the endoscopist searching for polyps and adenomas (mn) |
| The frequency of adverse events (AEs) | within 10 minutes post procedure | including nausea, vomiting, abdominal bloating - and their severity, |
| volume of bowel preparation ingested | immediately post procedure | in ml |
| Caecal intubation rate | immediately post procedure. | successful Caecal intubation |
Countries
France
Outcome results
None listed