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

NYU Langone Health1 site in 1 countryOctober 2014

ConditionsColonoscopy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colonoscopy
Sponsor: NYU Langone Health
Locations: 1
Primary Endpoint: Comparison of Boston Bowel Prep Score (BBPS)
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Difference in the number of follow ups needed after colonoscopy(1 Day)
Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)(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)(1 Day)
Difference in Adenoma Detection Rate (ADR)(1 Day)