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

NCT06319924 | Completed

• 1 other identifier: XIMEPEG-RL
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 5

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.

Conditions

Colorectal Cancer; Colonoscopy; Bowel Preparation Solution

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Colonoscope removal time

  immediately post procedure

• The frequency of adverse events (AEs)

  within 10 minutes post procedure

• volume of bowel preparation ingested

  immediately post procedure

• Caecal intubation rate

  immediately post procedure.

Interventions

Simethicone combined with Macrogol 4000 (PEG) DRUG

bowel preparation product for colonoscopy as part of CRC screening

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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,

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (5)

Clinique des Cèdres, Ramsay Santé,

Cornebarrieu, 31700, France

Location

Polyclinique Louis Pasteur,

Essey-lès-Nancy, 54280, France

Location

Saint Joseph Hospital

Marseille, 13008, France

Location

5. Clinique Ambroise Paré

Toulouse, 31082, France

Location

Pole Santé des Haberges

Vesoul, 70000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 20, 2024
• Study Start: February 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: September 15, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)