Effect of Adding Simethicone to Split-dose Polyethylene Glycol for Bowel Preparation in a Screening Colonoscopy Setting

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Portuguese Oncology Institute, Coimbra
• Treatments: Simethicone

Criteria

Inclusion criteria:

• consecutive patients scheduled for colonoscopy by nationwide CRC screening program after a positive faecal immunochemical test,

• signed informed consent.

Exclusion criteria:

• previous diagnosis of CRC,

• presence of known genetic susceptibility syndromes related with CRC,

• personal history of inflammatory bowel disease,

• presence of gastrointestinal complaints (significant changes in gastrointestinal transit in the last 6 months or evidence of gastrointestinal bleeding),

• a normal colonoscopy in the last 10 years and a normal flexible sigmoidoscopy in the last 5 years,

• known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection,

• pregnant or at risk of becoming pregnant and lactating women,

• known or suspected hypersensitivity to the active or other ingredients.