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

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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

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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Device: Aquanet Drug: Sodium Picosulfate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation: Propensity Score Analysis for Interventional Effectiveness Evaluation
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.
Drug: Sodium Picosulfate
Sodium Picosulfate solution (Picoprep)

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.
Device: Aquanet
Aquanet bowel cleansing devices




Primary Outcome Measures :
  1. Quality of bowel preparation [ Time Frame: 16 weeks ]
    Evaluated through the Boston Bowel Preparation (BBP) scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074448


Locations
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Brazil
Kaiser Clinica and Day Hospital
Sao Jose do Rio Preto, SP, Brazil
Sponsors and Collaborators
Kaiser Clinic and Hospital
Investigators
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Principal Investigator: Roberto Luiz kaiser Júnior, MD, PhD Kaiser Clinica and Day Hospital
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Responsible Party: Kaiser Clinic and Hospital
ClinicalTrials.gov Identifier: NCT03074448    
Other Study ID Numbers: Kaiser CH
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Keywords provided by Kaiser Clinic and Hospital:
Colonoscopy
Intestinal Cleaning
Picoprep
Aquanet
Additional relevant MeSH terms:
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Picosulfate sodium
Cathartics
Gastrointestinal Agents