The Effects of Moviprep With Simethicone on Colonic Bubbles

Thomas Jefferson University

Status: Completed

Conditions: Bubbles in Colon at Time of Colonoscopy

Treatments: Drug: simethicone

Study type: Interventional

Funder types: Other

Identifiers

NCT01209806

#09D.472

Details and patient eligibility

About

The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.

Full description

evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid

Exclusion criteria

• Unable or unwilling to give informed consent
• Age < 18 years
• Pregnant
• Breast feeding
• Established or suspected gastroparesis
• Pseudo-obstruction - established or suspected
• Severe constipation (< 1 BM a week)
• Bowel obstruction
• Greater than 50% resection of colon
• Chronic nausea or vomiting
• Consumed > 100% standard dose of PEG-ELS (i.e. more than 2L)
• G6PD deficiency
• PEG allergy
• Significant psychiatric illness

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

simethicone

Active Comparator group

Treatment:

Drug: simethicone

no simethicone

No Intervention group