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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely | Active Comparator |
| |
| Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golytely | Drug | Bowel cleanliness and patient tolerability |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Procedural (during the participant's screening colonoscopy) |
| 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. | Pre-procedural (prior to the participant's screening colonoscopy) |
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Inclusion Criteria:
Exclusion Criteria:
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
Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
Pregnant or breast-feeding women or those who plan to become pregnant during the study
Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
History of colorectal cancer
Inflammatory Bowel Disease
Past surgical history of colon resection
Prior history of colorectal surgery
Family history of hereditary polyposis and cancer disorders to include but not limited to FAP (Familial Adenomatous Polyposis), Gardner Syndrome, Turcot Syndrome, Lynch Syndrome, Cowden Syndrome, and Peutz-Jeghers Syndrome
Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Darrell F Barker MD, FACG, MD | Contact | 706-836-9829 | darrell.f.barker.mil@health.mil |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dwight D. Eisenhower Army Medical Center | Recruiting | Fort Gordon | Georgia | 30905 | United States |
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| ID | Term |
|---|---|
| C033608 | Golytely |
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| SUPRPEP | Drug | Bowel cleanliness and patient tolerability |
|