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Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074448
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kaiser Clinic and Hospital

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE March 8, 2017
Last Update Posted Date March 8, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
Quality of bowel preparation [ Time Frame: 16 weeks ]
Evaluated through the Boston Bowel Preparation (BBP) scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation
Official Title  ICMJE Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation: Propensity Score Analysis for Interventional Effectiveness Evaluation
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bowel Preparation
Intervention  ICMJE
  • Device: Aquanet
    Aquanet bowel cleansing devices
  • Drug: Sodium Picosulfate
    Sodium Picosulfate solution (Picoprep)
Study Arms  ICMJE
  • Active Comparator: Sodium Picosulfate solution (Picoprep)
    On the eve of the examination, all participants on Sodium picosulfate will take 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.
    Intervention: Drug: Sodium Picosulfate
  • Experimental: Aquanet bowel cleansing devices
    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 was previously triple-filtered by passage on carbon, micro-pellets and ultraviolet light. The preparation will be carried out by a trained nurse.
    Intervention: Device: Aquanet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2017)
314
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women, aged 14-90 years
  • Must have had >3 spontaneous bowel movements per week for one month prior to the colonoscopy.
  • Willing and able to complete the entire process, comply with study instructions, and understand and sign the informed consent.

Exclusion Criteria:

  • Pregnancy (women of childbearing age underwent a pregnancy test at screening and again at randomization).
  • Acute abdominal surgical conditions (acute obstruction or perforation).
  • Prior colorectal surgery (excluding appendectomy), hemorrhoid surgery or endoscopic procedures.
  • Bowel disease (colon cancer history, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome).
  • Gastrointestinal disorders (active ulcer, output obstruction, retention, gastroparesis, ileus).
  • Upper gastrointestinal surgery (gastrectomy, gastric band, gastric bypass).
  • Uncontrolled angina and/or myocardial infarction (MI) within the last 3 months; congestive heart failure (CHF) or uncontrolled hypertension.
  • Renal impairment (serum, creatinine and potassium must be within normal limits).
  • Participation in a research study within 30 days before receiving the study medication (or within 60 days for investigation of drugs with a half-life disposal of more than 15 days).
  • Hypersensitivity to active ingredients.
  • Chronic kidney disease.
  • Latex allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03074448
Other Study ID Numbers  ICMJE Kaiser CH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Clinic and Hospital
Study Sponsor  ICMJE Kaiser Clinic and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Luiz kaiser Júnior, MD, PhD Kaiser Clinica and Day Hospital
PRS Account Kaiser Clinic and Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP