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

NCT03074448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2017-03-08

No results posted yet for this study

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

Interventions

DEVICE

Aquanet

Aquanet bowel cleansing devices

DRUG

Sodium Picosulfate

Sodium Picosulfate solution (Picoprep)

Sponsors & Collaborators

  • Kaiser Clinic and Hospital

    lead OTHER

Principal Investigators

  • Roberto Luiz kaiser Júnior, MD, PhD · Kaiser Clinica and Day Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074448 on ClinicalTrials.gov