Feasibility and Effectiveness of Colonic Irrigation

Study Overview
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Brief Summary
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This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early detection.

Detailed Description
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The primary endpoints for this study are: Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) (6). Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.

Official Title
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Feasibility and Effectiveness of Colonic Irrigation as a Non-oral, Same-day Bowel Preparation Option in Patients Undergoing Screening or Surveillance Colonoscopy

Conditions
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Colonic Irrigation

Intervention / Treatment
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* Procedure: Colonic Irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients age 50-84 years old, who require a screening or surveillance colonoscopy Ability to give consent Exclusion Criteria: Pregnancy History of ulcerative colitis or Crohn's disease History of surgical ostomy History of colorectal surgery

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 84 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonic Irrigation<br>A designated health professional will administer to the patient the colonic irrigation procedure -using the Hydro-San Plus colon therapy system, an FDA approved and ISO certified device for colonic irrigation and cleansing before endoscopic procedures (FDA #2027347). | Procedure: Colonic Irrigation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS) | Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) | 15 Minutes | 
| Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy. |  | 15 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydro-San Plus colonic irrigation system, Screening colonoscopy