Colon Cancer Screening
Conditions
Brief summary
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.
Interventions
DRUGGolytely
Bowel cleanliness and patient tolerability
DRUGSUPRPEP
Bowel cleanliness and patient tolerability
Sponsors
Eisenhower Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Diabetic volunteer (defined per current ACP guidelines, and any type of DM) 3. Aged 18+ years, inclusive 4. Average screening risk, polyp surveillance, and family history of cancer
Exclusion criteria
1. 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 2. 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 3. Persistent significant or severe infection, either acute or chronic 4. Prior use of any investigational drug in the preceding 6 months 5. 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). 6. Pregnant or breast-feeding women or those who plan to become pregnant during the study 7. Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest): 1. Hematocrit \< 35% and/or 2. Absolute white blood cell count \< 3000 cells/mm3 ( L) and/or 3. Platelet count \< 150 000 cells/mm3 ( L) and/or- Absolute neutrophil = 1500 cells/mm3 ( L) 8. History of colorectal cancer 9. Inflammatory Bowel Disease 10. Past surgical history of colon resection 11. Prior history of colorectal surgery 12. 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 13. Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel cleanliness using the Boston Bowel Prep Score (BBPS) | Procedural (during the participant's screening colonoscopy) | 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. |
| Use of the Mayo Bowel Prep Tolerability Score (MTS) | Pre-procedural (prior to the participant's screening colonoscopy) | 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. |
Countries
United States
Contacts
CONTACTDarrell F Barker MD, FACG, MD
Outcome results
None listed