Colon Cancer, Colonic Polyp
Conditions
Keywords
colonoscopy, bowel prep, screening
Brief summary
Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology & Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. As a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. However, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals. Given that the patient population described above are often not well-known to UVA providers, they may be prescribed prep regimens that are not ideal for their comorbidities. Not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection. The investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. Because obtaining written consent is not practical given that these patients may not be seen by a UVA provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. Subjects be prescribed either a standard split-dose GoLytely prep (or SuPrep) or an extended split-dose GoLytely prep. The investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. The investigators will work with a UVA biostatistician to analyze the data and use Chi Square, student's T tests, and logistic regression models to assess significance and help validate the model.
Interventions
OTHEROrton Score
Significant a priori predictors of poor prep included: male gender, COPD, diabetes with end-organ damage, severe neurologic disease, constipation medication use, and tricyclic antidepressant use. Proprietary web-based weighted scoring model allows screening clinician to predict which bowel prep would be best for patient depending on which risk factors patients have.
OTHERTypical Standard of Care
Clinician usual practice of prescribing bowel preps to patient
Sponsors
University of Virginia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
All patients will be assessed for the most appropriate bowel preparation prior to colonoscopy (standard vs. extended) based on a novel scoring tool that accounts for various clinical conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older (up to 100 years) * Referred for open access colonoscopy from an outside provider/UVA provider * Able to provide informed consent
Exclusion criteria
* Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inadequate prep rate | Through study duration, approximately 1 year | Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate (ADR) | Through study duration, approximately 1 year | Percentage of colonoscopies with detection of at least 1 adenoma |
| Polyp burden | Through study duration, approximately 1 year | Mean # of polyps found per colonoscopy |
| Advanced adenoma / adenocarcinoma detection rate | Through study duration, approximately 1 year | Percentage of colonoscopies with detection of an adenoma with high-grade dysplasia, tubulovillous adenoma, or adenocarcinoma |
| Incomplete colonoscopy rate | Through study duration, approximately 1 year | Percentage of colonoscopies that are unable to be completed secondary to inadequate prep or technical difficulty |
Countries
United States
Outcome results
None listed