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

Completed

• Conditions: Colonoscopy; Colorectal Cancer; Bowel Preparation Solution

• Registration Number: NCT06319924
• Lead Sponsor: Hospital St. Joseph, Marseille, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-05-31
• Study Completion: 2022-09-15
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)	During procedure
Assess the quality of the bowel preparation assessed by Bubble scale	During procedure

Secondary Outcome Measures

Name	Time	Method
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,
Caecal intubation rate	immediately post procedure.	successful Caecal intubation
volume of bowel preparation ingested	immediately post procedure	in ml

Trial Locations

Locations (5)

Clinique des Cèdres, Ramsay Santé,; 🇫🇷 Cornebarrieu, France

Polyclinique Louis Pasteur,; 🇫🇷 Essey-les-Nancy, France

Saint Joseph Hospital; 🇫🇷 Marseille, France

5. Clinique Ambroise Paré; 🇫🇷 Toulouse, France

Pole Santé des Haberges; 🇫🇷 Vesoul, France