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Improving Outpatient Colonoscopy Bowel Prep With the Orton Score

Primary Purpose

Colonic Polyp, Colon Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orton Score
Typical Standard of Care
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colonic Polyp focused on measuring colonoscopy, bowel prep, screening

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Other

Arm Label

Orton Score Cohort - High

Prospective Orton Score Cohort - Low

Retrospective Cohort (before Orton Score)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Inadequate prep rate
Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance)

Secondary Outcome Measures

Adenoma detection rate (ADR)
Percentage of colonoscopies with detection of at least 1 adenoma
Polyp burden
Mean # of polyps found per colonoscopy
Advanced adenoma / adenocarcinoma detection rate
Percentage of colonoscopies with detection of an adenoma with high-grade dysplasia, tubulovillous adenoma, or adenocarcinoma
Incomplete colonoscopy rate
Percentage of colonoscopies that are unable to be completed secondary to inadequate prep or technical difficulty

Full Information

First Posted
September 13, 2019
Last Updated
May 24, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04093557
Brief Title
Improving Outpatient Colonoscopy Bowel Prep With the Orton Score
Official Title
Validation of a Novel Clinical Prediction Scoring System for Improved Bowel Preparation Prior to Outpatient Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2024 (Anticipated)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colon Cancer
Keywords
colonoscopy, bowel prep, screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orton Score Cohort - High
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prospective Orton Score Cohort - Low
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Retrospective Cohort (before Orton Score)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Orton Score
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Typical Standard of Care
Intervention Description
Clinician usual practice of prescribing bowel preps to patient
Primary Outcome Measure Information:
Title
Inadequate prep rate
Description
Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance)
Time Frame
Through study duration, approximately 1 year
Secondary Outcome Measure Information:
Title
Adenoma detection rate (ADR)
Description
Percentage of colonoscopies with detection of at least 1 adenoma
Time Frame
Through study duration, approximately 1 year
Title
Polyp burden
Description
Mean # of polyps found per colonoscopy
Time Frame
Through study duration, approximately 1 year
Title
Advanced adenoma / adenocarcinoma detection rate
Description
Percentage of colonoscopies with detection of an adenoma with high-grade dysplasia, tubulovillous adenoma, or adenocarcinoma
Time Frame
Through study duration, approximately 1 year
Title
Incomplete colonoscopy rate
Description
Percentage of colonoscopies that are unable to be completed secondary to inadequate prep or technical difficulty
Time Frame
Through study duration, approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian J Wentworth, MD
Phone
9739436781
Email
bw8xz@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Steven M Powell, MD
Phone
(434) 924-2626
Email
smp9n@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M Powell, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian J Wentworth, MD
Phone
973-943-6781
Email
bw8xz@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Steven M Powell, MD
Phone
(434) 924-2626
Email
smp9n@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Steven M Powell, MD
First Name & Middle Initial & Last Name & Degree
Brian J Wentworth, MD
First Name & Middle Initial & Last Name & Degree
Esteban Figueroa, MD
First Name & Middle Initial & Last Name & Degree
Kimberly Richards, NP
First Name & Middle Initial & Last Name & Degree
Cindy Gentry, RN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Improving Outpatient Colonoscopy Bowel Prep With the Orton Score

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