CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 412 enrolled
Drug / intervention
PEG split-dose and simethiconedrug
Likely dose
PEG split-dose and simethicone 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03816774
NCT03816774N/ACompleted

Effect of Adding Simethicone to a Split Regimen of Polyethylene Glycol for Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: an Endoscopist-blinded Randomized Controlled Trial

Portuguese Oncology Institute, Coimbra·interventional·Posted Jan 25, 2019·Updated Oct 5, 2022

In Brief

A clinical study evaluating PEG split-dose and simethicone for Colo-rectal Cancer and Colonic Neoplasms. Completed, enrolled 412 participants across 1 site.

Detailed Summary

Colonoscopy is currently accepted as the gold standard in screening, surveillance and prevention for colorectal cancer (CRC), and therefore, its quality is a major priority. The quality of colonoscopy is greatly dependent on the quality of the bowel preparation. Standard bowel cleansing includes a low-fibre diet on the day preceding the exam and a split regimen of 4 litres of polyethylene glycol (PEG) solution. In order to improve bowel cleansing some additional measures are available. Simethicone is an inexpensive and safe antifoaming agent that reduces the surface tension of air bubbles, theoretically presenting several benefits such as increased tolerability to the preparation, thereby improving the quality of the preparation and, secondly, adenoma detection (ADR) and cecal intubation rates (CIR). However, its role remains controversial, with some publications supporting its administration and others failing to demonstrate clear benefits. The main aim of this study is to assess if addition of simethicone to a split-dose cleansing regimen of 4 litres of PEG improves adequate bowel preparation rate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartJun 15, 2019
Primary CompletionSep 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.4 years ago

Interventions

PEG split-dose and simethiconedrug

Patients in active comparator arm are instructed to take 250mg simethicone pill 15 minutes before PEG dose on the previous evening plus 250mg simethicone pill 15 minutes before PEG dose ending 3 hours before colonoscopy