Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      An adequate bowel preparation has been well established to lead to a successful colonoscopy.
      Research has consistently demonstrated inadequate bowel preparation with lower adenoma
      detection rates. Over the years, endoscopy centers have changed the constituents of bowel
      preparation in light of new research. In 2006, 3 medical organizations recommended the use of
      polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution
      was commonly used using a split dose regimen for bowel prep. However, many patients found
      that this large volume gave them side effects including bloating and cramping. Other studies
      showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy
      of bowel preparation. With the institution of lower volume PEG preparation our offices noted
      improved patient toleration, satisfaction, and clinical outcomes. However, multiple
      endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume
      preparation. This can impair proper visualization of the bowel wall even with an adequate
      bowel preparation. The current standard of practice includes irrigation, lavage, and
      suctioning using a simethicone infused saline during the colonoscopy. Its property of
      reducing surface tension to help dissolve bubbles and clear the field of view is vital during
      the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is
      considered rather safe.

      This study evaluates whether the addition of oral simethicone with the colonoscopy bowel
      preparation reduces bubbles and foam during the procedure using a randomized and controlled
      interventional study.
    

Detailed description: 
      This prospective, multi-center, randomized, controlled, double (patient and endoscopist)
      blinded study is conducted at the Gastroenterology Consultants outpatient clinics and
      endoscopy centers in association with the University of Nevada-Reno School of Medicine. After
      obtaining signed informed consent, outpatients are recruited and randomized into 1 of 2
      treatment groups; PEG3350-Bisacodyl with 200 mg liquid simethicone treatment and
      PEG3350-Bisacodyl treatment with inert placebo (water).

      The primary outcome includes reduction of bubbles using the intraluminal bubbles scale.
      Secondary outcomes include the evaluations of the numbers and types of polyps, numbers and
      types of masses detected, cecal insertion time, withdrawal time, adverse effects, and the
      adequacy of bowel prep using the Boston Bowel Prep scale.
    

Intervention name(s): Simethicone Solution; Water
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg of Simethicone in 3 mL of Simethicone Solution Formulation; 3 mL of water as placebo added to the bowel preparation
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Bowel wall visualization; Intraluminal bubbles; Intraluminal foam; Simethicone