Colonic Irrigation for Colonoscopy Preparation

September 27, 2016 updated by: NYU Langone Health

Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy

The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive adult patients (>18 years old) who require screening or surveillance colonoscopy
  • Ability to give consent

Exclusion Criteria:

  • Inability to obtain informed consent
  • Pregnant patients
  • Patients under the age of 18
  • Active ulcerative colitis or crohn's disease flare
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isosmotic bowel cleansing preparation
Isosmotic solution ingested prior to colonoscopy
Other: Isosmotic bowel cleansing preparation
Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
Active Comparator: Colonic Hyrdrotherapy
Colonic hydrotherapy is an FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician.2 There
Other: Colonic Hyrdrotherapy
FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician
Other Names:
  • Hydro San Plus Colon therapy system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Boston Bowel Prep Score (BBPS)
Time Frame: 1 Day
Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)
1 Day

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in Adenoma Detection Rate (ADR)
Time Frame: 1 Day
1 Day
Difference in the number of follow ups needed after colonoscopy
Time Frame: 1 Day
1 Day
Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Time Frame: 1 Day
1 Day
preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Basil Lucak, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 14-01351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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