Clinical trial NCT06319924: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy
Official title: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy: Phase 4 Prospective Multicenter Real Life Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colonoscopy
Bowel Preparation Solution
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 601
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Assess the quality of the bowel preparation assessed by Bubble scale
timeFrame: During procedure
measure: Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)
timeFrame: During procedure
Secondary outcomes:
measure: Colonoscope removal time
timeFrame: immediately post procedure
measure: The frequency of adverse events (AEs)
timeFrame: within 10 minutes post procedure
measure: volume of bowel preparation ingested
timeFrame: immediately post procedure
measure: Caecal intubation rate
timeFrame: immediately post procedure.
Other outcomes:
Locations:
city: Cornebarrieu
country: France
facility: Clinique des Cèdres, Ramsay Santé,
city: Essey-les-Nancy
country: France
facility: Polyclinique Louis Pasteur,
city: Marseille
country: France
facility: Saint Joseph Hospital
city: Toulouse
country: France
facility: 5. Clinique Ambroise Paré
city: Vesoul
country: France
facility: Pole Santé des Haberges
Study officials:
References: