Colonic Irrigation for Colonoscopy Preparation

Not Applicable

Withdrawn

• Conditions: Colonoscopy
• Interventions: Other: Colonic Hyrdrotherapy; Other: Isosmotic bowel cleansing preparation

• Registration Number: NCT02647229
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonic Hyrdrotherapy	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
Isosmotic bowel cleansing preparation	Isosmotic bowel cleansing preparation	Isosmotic solution ingested prior to colonoscopy

Primary Outcome Measures

Name	Time	Method
Comparison of Boston Bowel Prep Score (BBPS)	1 Day	Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States