Colonic Irrigation for Colonoscopy Preparation
Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
2 years
December 22, 2015
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of Boston Bowel Prep Score (BBPS)
Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)
1 Day
Secondary Outcomes (4)
Difference in Adenoma Detection Rate (ADR)
1 Day
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
Study Arms (2)
Isosmotic bowel cleansing preparation
ACTIVE COMPARATORIsosmotic solution ingested prior to colonoscopy
Colonic Hyrdrotherapy
ACTIVE COMPARATORColonic 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
Interventions
Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician
Eligibility Criteria
You may qualify if:
- Consecutive adult patients (\>18 years old) who require screening or surveillance colonoscopy
- Ability to give consent
You may not qualify if:
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Active ulcerative colitis or crohn's disease flare
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Basil Lucak
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
January 6, 2016
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09