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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Colonoscopy Bowel Preparation Solution

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Simethicone combined with Macrogol 4000 (PEG)

bowel preparation product for colonoscopy as part of CRC screening

Intervention Type DRUG

Eligibility Criteria

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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.