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
|Condition or disease||Intervention/treatment||Phase|
|Bowel Preparation||Device: Aquanet Drug: Sodium Picosulfate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||314 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
Aquanet bowel cleansing devices
- Quality of bowel preparation [ Time Frame: 16 weeks ]Evaluated through the Boston Bowel Preparation (BBP) scale.
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
|Kaiser Clinica and Day Hospital|
|Sao Jose do Rio Preto, SP, Brazil|
|Principal Investigator:||Roberto Luiz kaiser Júnior, MD, PhD||Kaiser Clinica and Day Hospital|