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unable to agree on budget terms
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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.
The level of cleanliness will be recorded using the Boston Bowel Prep Score (BBPS) by an endoscopist who is blind to the randomized preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: HyGIeaCare Prep and Colonoscopy | Active Comparator | Patients will receive:
|
|
| 2: Split-dose PEG Prep and Colonoscopy | Active Comparator | Patients will receive:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyGIeaCare Prep | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS) | Day 1 of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of patient satisfaction using a Questionnaire | Questionnaire | 2 Days after colonoscopy |
| Evaluation of adverse events | Questionnaire |
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Inclusion Criteria:
Patient referred to colonoscopy
Patient with high probability for poor prep due to one or more of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Umar, MD | Mayo Clinic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25239068 | Background | Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available. | |
| Background | Gagneja HK, Parekh P, Burleson D, Johnson D. HyGIeaCare® Preparation for Colonoscopy - A Technical Update for Success. J Gastrointest Dig Syst 2016; 6: 458. doi:10.4172/2161-069X.1000458 | ||
| 26439436 |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Colonoscopy | Procedure | Screening colonoscopy as per standard of care. |
|
|
| polyethylene glycol (PEG) | Drug | PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy |
|
|
| 2 Days after colonoscopy |
| Background |
| Clark BT, Protiva P, Nagar A, Imaeda A, Ciarleglio MM, Deng Y, Laine L. Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology. 2016 Feb;150(2):396-405; quiz e14-5. doi: 10.1053/j.gastro.2015.09.041. Epub 2015 Oct 9. |
| Background | Fiorito J, Culpepper-Morgan JA, Estabrook SG, Scofield P, Usatii V, Cuomo R. Hydrotherapy Compared with PEG-ES Lavage and Aqueous Sodium Phosphate as Bowel Preparation for Elective Colonoscopy: A Prospective, Randomized, Single Blinded Trial. ACG Abstract 2006; 751814. |
| Background | Sportes A, Delvaux M, Huppertz J, Hernandez C, Gay G. Randomized Trial Comparing High Volume Rectal Water Irrigation with Standard 4L Split-dose PEG Preparation Before Colonoscopy. Accepted by Gastroenterology and Digestive Diseases (awaiting publication). |
| 25595062 | Background | ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available. |
| Background | US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009. |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |