Colonoscopy Bowel Prep Comparison Among Diabetic Patients
ConditionColon Cancer Screening
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEisenhower Army Medical Center
About this trial
The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are:
1. Is there a significant difference in bowel prep cleanse between Golytely and SUPREP in patients with diabetes based on the Boston Bowel Prep Score (BBPS) as assessed by blinded, skilled endoscopists? 2. Is there a significant difference in patients' tolerance between the bowel preparations as assessed by the validated Mayo Bowel Prep Tolerability Form (MBPTF)?
Participants will:
* Be randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy * Complete the MBPTF on the procedure date prior to the scheduled colonoscopy * Undergo a standardized screening colonoscopy during which time a blinded endoscopist will document the participant's BBPS
The research team hypothesizes that SUPREP will have a significant difference in tolerability (based on MBPTF), while exhibiting no difference in bowel cleanse (based on BBPS) in the diabetic patient population.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
Aged 18+ years, inclusive
Average screening risk, polyp surveillance, and family history of cancer
Disqualifiers
Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
Persistent significant or severe infection, either acute or chronic
Prior use of any investigational drug in the preceding 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Golytely
DrugBowel cleanliness and patient tolerability
SUPRPEP
DrugBowel cleanliness and patient tolerability
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Diabetic patients undergoing bowel prep for screening colonoscopy using GolytelyActive comparator 1 intervention
Group B: Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bowel cleanliness using the Boston Bowel Prep Score (BBPS)
The BBPS uses a score from 0-9 which helps quantify bowel cleanliness after bowel prep prior to colonoscopy. A higher score indicates better visualization of the colon mucosa. This will be assessed by blinded, skilled endoscopists.
Time frame
Procedural (during the participant's screening colonoscopy)2
Use of the Mayo Bowel Prep Tolerability Score (MTS)
The questionnaire is a validated scoring system used to assess the tolerability (ex. symptoms) and experience (ex. likelihood of using the bowel prep again) among diabetic patients undergoing the study.
Time frame
Pre-procedural (prior to the participant's screening colonoscopy)Sponsors and contacts
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Source ClinicalTrials.gov