Clinical trial NCT02893748: HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
Official title: HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonoscopy
Keywords: colon
polyps
cancer
screening
Lead sponsor: HyGIeaCare, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)
timeFrame: Day 1 of colonoscopy
Secondary outcomes:
measure: Evaluation of patient satisfaction using a Questionnaire
timeFrame: 2 Days after colonoscopy
measure: Evaluation of adverse events
timeFrame: 2 Days after colonoscopy
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Sarah Umar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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).
citation: 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.
citation: US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.