HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs the standard of care Split-dose PEG prep used prior to colonoscopy.

Detailed Description
-----------------
The level of cleanliness will be recorded using the Boston Bowel Prep Score (BBPS) by an endoscopist who is blind to the randomized preparation.

Official Title
-----------------
HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Device: HyGIeaCare Prep
* Procedure: Colonoscopy
* Drug: polyethylene glycol (PEG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient referred to colonoscopy Patient with high probability for poor prep due to one or more of the following: Chronic constipation (Rome III functional constipation criteria) Gastroparesis Immobilization Diabetes History of poor prep Exclusion Criteria: Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study. Patient is currently taking narcotics. Patient has any of the contraindications listed below: Cardiac: Congestive heart failure (NYHA class III or IV or EF < 50%) GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites Abdominal surgery within the last 6 months Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: HyGIeaCare Prep and Colonoscopy<br>Patients will receive: HyGIeaCare Prep Colonoscopy | Device: HyGIeaCare Prep<br>* Patients will receive the HyGIeaCare Prep, which is an open colon lavage system using warm water by gravity drip to evacuate the colon by stimulating peristalsis to cleanse the colon prior to colonoscopy.<br>* Other names: colon lavage;Procedure: Colonoscopy<br>* Screening colonoscopy as per standard of care.<br>* Other names: Screening Colonoscopy;|
| Active Comparator: 2: Split-dose PEG Prep and Colonoscopy<br>Patients will receive: Split-dose PEG Colonoscopy | Procedure: Colonoscopy<br>* Screening colonoscopy as per standard of care.<br>* Other names: Screening Colonoscopy;Drug: polyethylene glycol (PEG)<br>* PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy<br>* Other names: Split-dose PEG Prep;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS) |  | Day 1 of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patient satisfaction using a Questionnaire | Questionnaire | 2 Days after colonoscopy | 
| Evaluation of adverse events | Questionnaire | 2 Days after colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon, polyps, cancer, screening