Colonic Irrigation for Colonoscopy Preparation

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Other: Isosmotic bowel cleansing preparation
* Other: Colonic Hyrdrotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |