The Effects of Moviprep With Simethicone on Colonic Bubbles

Not Applicable

Completed

• Conditions: Bubbles in Colon at Time of Colonoscopy
• Interventions: Drug: simethicone

• Registration Number: NCT01209806
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simethicone	simethicone	-

Primary Outcome Measures

Name	Time	Method
Efficacy - Entire colon	At time of colonoscopy	Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate

Secondary Outcome Measures

Name	Time	Method
Efficacy - Right colon	At time of colonoscopy	Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
Adenoma detection	at time of colonoscopy	Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma
Flushing	at time of colonoscopy	Defined as need for any (1, 2, or 3) flushing; • 0 = none, 1 = \<50 ml, 2 = 50-100 ml, 3 = \>100 ml
Tolerance	during prep ingestion	Prep completion; • Completion defined as consuming \> 90%; Sleep; * Primary definition as quality of sleep; * Also evaluate duration of sleep Overall satisfaction; * Use visual analogue (Likert) scale Adverse events - nausea, vomiting, abdominal pain, bloating, light-headedness; * Primary is incidence; * Secondary is severity using Likert scale
Safety	at time of colonoscopy	Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States