Improving Outpatient Colonoscopy Bowel Prep with the Orton Score
- Conditions
- Colonic PolypColon Cancer
- Interventions
- Other: Orton ScoreOther: Typical Standard of Care
- Registration Number
- NCT04093557
- Lead Sponsor
- University of Virginia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 500
- Age 18 or older (up to 100 years)
- Referred for open access colonoscopy from an outside provider/UVA provider
- Able to provide informed consent
- Prisoners
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orton Score Cohort - High Orton Score Patients will be scored using the "Orton Score," a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they score highly, they will receive an extended GoLytely bowel prep. Retrospective Cohort (before Orton Score) Typical Standard of Care - Prospective Orton Score Cohort - Low Orton Score Patients will be scored using the "Orton Score," a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they do not score highly, they will receive a standard GoLytely (or Suprep) bowel prep.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Polyp burden Through study duration, approximately 1 year Mean # of polyps found per colonoscopy
Adenoma detection rate (ADR) Through study duration, approximately 1 year Percentage of colonoscopies with detection of at least 1 adenoma
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
Trial Locations
- Locations (1)
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States