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

NCT03074448 | Completed Phase 3 DMC

• 1 other identifier: Kaiser CH
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Keywords

Colonoscopy; Intestinal Cleaning; Picoprep; Aquanet

Outcome Measures

Primary Outcomes (1)

• Quality of bowel preparation

  Evaluated through the Boston Bowel Preparation (BBP) scale.

  16 weeks

Study Arms (2)

Sodium Picosulfate solution (Picoprep)

ACTIVE COMPARATOR

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

Aquanet bowel cleansing devices

EXPERIMENTAL

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

Interventions

Aquanet DEVICE

Aquanet bowel cleansing devices

Aquanet bowel cleansing devices

Sodium Picosulfate DRUG

Sodium Picosulfate solution (Picoprep)

Sodium Picosulfate solution (Picoprep)

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (1)

Kaiser Clinica and Day Hospital

São José do Rio Preto, São Paulo, Brazil

Location

MeSH Terms

Interventions

picosulfate sodium

Study Officials

• Roberto Luiz kaiser Júnior, MD, PhD

  Kaiser Clinica and Day Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: March 8, 2017
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

BR (1)