Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      Poor or inadequate bowel preparation is one of the most common reasons for a repeated or
      failed colonoscopy. Preparation methods shown to be effective include the use of either
      bowel-cleansing devices or oral laxatives. Despite the acceptable effectiveness and safety of
      both bowel-cleansing methods, very few studies have been performed to evaluate which method
      is more effective. The main aim is to perform an observational study followed by propensity
      score modeling to evaluate and compare the quality of bowel preparation with the use of
      Aquanet bowel-cleansing devices versus the use of oral Sodium picosulfate solution. The study
      will involve 314 patients requiring a colonoscopy, between 14 and 90 years of age and with
      more than three bowel movements per week for the past one month. Outcomes of interest being
      the quality of bowel preparation evaluated through the Boston Bowel Preparation (BBP) scale.
      The investigator hypothesized that the bowel preparation with Aquanet bowel-cleansing device
      for colonoscopy will provide a better outcome for the patient than with conventional methods.
    

Detailed description: 
      The study will compare the quality of pre-endoscopic bowel preparation using a
      bowel-cleansing device with oral Sodium picosulfate solution. The study will be described in
      accordance with the STROBE (Strengthening the Reporting of Observational studies in
      Epidemiology) guidelines.

      Ethical aspects: The study will undergo full review by the local Institutional Review Board,
      all potential participants being provided with informed consent. Study protocol will only be
      initiated after consent is signed.

      Settings: Data will be collected from June 2014 to February 2015 at the Portuguese Charitable
      Hospital, located in Sao Jose do Rio Preto/SP, Brazil. The Kaiser clinic, a private
      institution, will pay for the Aquanet devices. The Aquanet devices were designed and tested
      by Prime Pacific Health Innovations Corporation
      (http://www.primepacifichealth.com/aquanet-family-of-colon-hydrotherapy-devices/), and
      approved by the various regulatory authorities for market approval and licensing including
      FDA , Health Canada, and the European Union
      (<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K000031>, last accessed
      October 2016). The Aquanet devices have been on the market since 2001. The procedure lasts
      for 40-60 min, using filtered, ultraviolet treated water. Water pressure is derived from
      gravity or from a pump with an upper safe limit of two psi (per square inch) of pressure
      inside the colon. The device cleanses the large bowel through a series of fill and empty
      cycles by hydrating the colon, stimulating peristalsis and evacuating bowel contents. The
      process keeps the body hydrated without losing electrolytes. No adverse events have been
      reported for the Aquanet devices and there have also been no complaints received to its
      safety. It may cause mild abdominal discomfort during water infusion in some patients.

      Participants: Inclusion criteria will involve all patients requiring a colonoscopy, those
      between 14 and 90 years of age, and with more than three bowel movements per week for the
      past one month. Patients will be excluded with following conditions: Pregnancy (confirmed by
      a pregnancy test), acute abdomen syndrome, prior colorectal surgery, hemorrhoids or
      endoscopic procedures, known bowel diseases (colon cancer history, toxic megacolon, toxic
      colitis, idiopathic pseudo obstruction, hypo-motility syndrome), other gastrointestinal
      disorders (active ulcer, output obstruction, retention, gastroparesis, ileus), previous upper
      gastrointestinal surgery (gastrectomy, gastric band, gastric bypass), uncontrolled angina
      and/or myocardial infarction (MI) within the last three months, congestive heart failure
      (CHF) or uncontrolled hypertension, renal impairment (serum, creatinine and potassium must be
      within normal limits) or known hypersensitivity to active ingredients. A total of 314
      patients will be part of this analysis.

      Outcome variables: Major outcome of interest will be the quality of bowel preparation as
      measured through the Boston Bowel Preparation (BBP) scale. Bowel preparation will be
      evaluated in three segments: The right segment (cecum and ascending colons), transverse
      segment (transverse colon including liver and splenic angles), and the left segment
      (descending and sigmoid colons and rectum). Each segment will be evaluated on a scale from
      0-3, and the final score for an individual was the sum of scores for all three segments.
      Using this score, 0 was the minimum score corresponding to an unprepared colon and 9 was the
      maximum score corresponding to an excellent preparation without any residual traces.

      Predicting variables: Main predictor will be the methods of bowel preparation. The bowel
      preparation will be done using either Sodium picosulfate or the bowel-cleansing device. On
      the eve of the examination, all participants on Sodium picosulfate will be given four tablets
      of Dulcolax with tea or water in the morning, liquid diet (juice, tea or water) at lunch, two
      capsules of 25mg Dramamine Capsgel in the afternoon, Sodium picosulfate dissolved in 150mL of
      cold water thirty minutes after, followed by drinking at least five 250-ml cups of water or
      other light liquids until midnight, with absolute fasting up to the time when the colonoscopy
      will be performed. For bowel preparation with the bowel cleansing device, intestinal lavage
      will be performed with the device, making use of water, pressure, and gravity to enhance
      bowel cleansing. The water used in this procedure will be previously triple-filtered by
      passage on carbon, micro-pellets and ultraviolet light. The preparation will be carried out
      by a trained nurse. All endoscopic procedures will be performed by an endoscopist who will be
      blinded to the method of preparation.
    

Intervention name(s): Aquanet; Sodium Picosulfate
Intervention type(s): Device; Drug
Intervention description(s): Aquanet bowel cleansing devices; Sodium Picosulfate solution (Picoprep)
Intervention MeSH terms: Picosulfate sodium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Colonoscopy; Intestinal Cleaning; Picoprep; Aquanet