Colonoscopy
Conditions
Keywords
colon, polyps, cancer, screening
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.
Interventions
DEVICEHyGIeaCare Prep
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.
PROCEDUREColonoscopy
Screening colonoscopy as per standard of care.
PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy
Sponsors
HyGIeaCare, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patient referred to colonoscopy 2. Patient with high probability for poor prep due to one or more of the following: 1. Chronic constipation (Rome III functional constipation criteria) 2. Gastroparesis 3. Immobilization 4. Diabetes 5. History of poor prep
Exclusion criteria
1. 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. 2. Patient is currently taking narcotics. 3. Patient has any of the contraindications listed below: 1. Cardiac: Congestive heart failure (NYHA class III or IV or EF \< 50%) 2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery 3. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites 4. Abdominal surgery within the last 6 months 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS) | Day 1 of colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of patient satisfaction using a Questionnaire | 2 Days after colonoscopy | Questionnaire |
| Evaluation of adverse events | 2 Days after colonoscopy | Questionnaire |
Outcome results
None listed