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Completed

NCT Number: NCT03410524

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastroenterology Consultants Reno - North Office and Endoscopy Center, Reno, Nevada, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simethicone Solution

Drug

200 mg of Simethicone in 3 mL of Simethicone Solution Formulation

Water

Drug

3 mL of water as placebo added to the bowel preparation

Primary outcomes

  1. Intraluminal Bubbles Scale

    Time frame: Data reported during colonoscopy.

    I >90% of the mucosal circumference seen II 90%-75% of the mucosal seen without foam or bubbles not requiring irrigation III 74% to 50% of the mucosa is free of foam or bubbles. Required irrigation IV <50% of the mucosa seen free of foam or bubbles. Required irrigation

Secondary outcomes

  1. Boston Bowel Preparation Scale

    Time frame: Data reported during colonoscopy.

  2. Cecal insertion time

    Time frame: Data reported during colonoscopy.

  3. Withdrawal time

    Time frame: Data reported during colonoscopy.

  4. Number of polyp

    Time frame: Data reported during colonoscopy.

  5. Type of polyp

    Time frame: Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy.

  6. Type of masses

    Time frame: Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy.

  7. Number of masses

    Time frame: Data reported during colonoscopy.

  8. Adverse effects

    Time frame: From the time of administration of the bowel preparation (day prior to colonoscopy) up until the time of the procedure preparation (pre-colonoscopy preparation). Estimated period of up to 24 hours.

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Collaborators

  • Gastroenterology Consultants

Registry information

Official study title

Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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