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Completed

NCT Number: NCT06319924

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

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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Key information

Conditions

Colorectal Cancer Bowel Preparation Solution Colonic Diseases Colonoscopy Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique des Cèdres, Ramsay Santé,, Cornebarrieu, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Simethicone combined with Macrogol 4000 (PEG)

Drug

bowel preparation product for colonoscopy as part of CRC screening

Primary outcomes

  1. Assess the quality of the bowel preparation assessed by Bubble scale

    Time frame: During procedure

  2. Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)

    Time frame: During procedure

Secondary outcomes

  1. Colonoscope removal time

    Time frame: immediately post procedure

    time spent by the endoscopist searching for polyps and adenomas (mn)

  2. The frequency of adverse events (AEs)

    Time frame: within 10 minutes post procedure

    including nausea, vomiting, abdominal bloating - and their severity,

  3. volume of bowel preparation ingested

    Time frame: immediately post procedure

    in ml

  4. Caecal intubation rate

    Time frame: immediately post procedure.

    successful Caecal intubation

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

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

Acronym: XIMEPEG-RL

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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