Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy

University of Nevada, Reno

Status and phase: Completed; Phase 3

Conditions: Colonoscopy

Treatments: Drug: Water; Drug: Simethicone Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03410524

1139179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible for outpatient elective colonoscopy
• Adult 18-80 years of age able to give consent.
• English speaking adults.

Exclusion criteria

• History of bowel resection
• Uncontrolled hypertension
• Suspected bowel perforation
• Suspected bowel obstruction
• Indications for emergent/urgent colonoscopy
• Non-english speaking individuals

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

Simethicone with PEG-3350 bisacodyl preparation

Active Comparator group

Description:

Treatment arm: 200 mg Simethicone in 3 mL of liquid formulation mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure.

Treatment:

Drug: Simethicone Solution

Placebo with PEG-3350 bisacodyl preparation

Placebo Comparator group

Description:

Placebo arm: 3 mL of water mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure.

Treatment:

Drug: Water