The Effects of Moviprep With Simethicone on Colonic Bubbles

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 2012

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

Interventions

  • Drug: simethicone
    • 400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy

Arms, Groups and Cohorts

  • Active Comparator: simethicone
  • No Intervention: no simethicone

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy – Entire colon
    • Time Frame: At time of colonoscopy
    • Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate

Secondary Measures

  • Efficacy – Right colon
    • Time Frame: At time of colonoscopy
    • Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
  • Adenoma detection
    • Time Frame: at time of colonoscopy
    • Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma
  • Flushing
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: at time of colonoscopy
    • Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thomas Jefferson University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Kastenberg, MD, Principal Investigator, Thomas Jefferson University

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