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

Colorectal Cancer Clinical Trial

— XIMEPEG-RL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06319924
• Other study ID #: XIMEPEG-RL
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: March 2024
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: September 15, 2022
• Est. primary completion date: May 31, 2021
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Colonoscopy
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Simethicone combined with Macrogol 4000 (PEG)
bowel preparation product for colonoscopy as part of CRC screening

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the quality of the bowel preparation assessed by Bubble scale		During procedure
Primary	Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)		During procedure
Secondary	Colonoscope removal time	time spent by the endoscopist searching for polyps and adenomas (mn)	immediately post procedure
Secondary	The frequency of adverse events (AEs)	including nausea, vomiting, abdominal bloating - and their severity,	within 10 minutes post procedure
Secondary	volume of bowel preparation ingested	in ml	immediately post procedure
Secondary	Caecal intubation rate	successful Caecal intubation	immediately post procedure.