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

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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colonoscopy; Bowel Preparation Solution
• Intervention / Treatment: Drug: Simethicone combined with Macrogol 4000 (PEG)

• Study Type: Observational
• Enrollment (Actual): 601

Contacts and Locations

Study Locations

• France
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres, Ramsay Santé,
  • Essey-les-Nancy, France, 54280
    • Polyclinique Louis Pasteur,
  • Marseille, France, 13008
    • Saint Joseph Hospital
  • Toulouse, France, 31082
    • 5. Clinique Ambroise Paré
  • Vesoul, France, 70000
    • Pole Santé des Haberges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients, scheduled for colonoscopy as part of CRC screening, were prospectively included according to the inclusion criteria

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscope removal time	time spent by the endoscopist searching for polyps and adenomas (mn)	immediately post procedure
The frequency of adverse events (AEs)	including nausea, vomiting, abdominal bloating - and their severity,	within 10 minutes post procedure
volume of bowel preparation ingested	in ml	immediately post procedure
Caecal intubation rate	successful Caecal intubation	immediately post procedure.

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: XIMEPEG-RL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO