Colonic Irrigation for Colonoscopy Preparation

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02647229
• Other study ID #: 14-01351
• Status: Withdrawn
• Phase: N/A
• First received: December 22, 2015
• Last updated: September 27, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Other:
• Isosmotic bowel cleansing preparation
Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
• 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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Boston Bowel Prep Score (BBPS)	Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)	1 Day	No
Secondary	Difference in Adenoma Detection Rate (ADR)		1 Day	No
Secondary	Difference in the number of follow ups needed after colonoscopy		1 Day	No
Secondary	Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)		1 Day	No
Secondary	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	No