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Orton Score System for Colonoscopy Preparation
N/A
Waitlist Available
Led By Steven M Powell, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Referred for open access colonoscopy from an outside provider/UVA provider
Age 18 or older (up to 100 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study duration, approximately 1 year
Summary
This trial is testing a new system for prescribing a specific bowel prep to patients most at risk for an inadequate prep, in order to decrease the number of incomplete or cancelled procedures.
Who is the study for?
This trial is for adults aged 18 to 100 who are referred for an open access colonoscopy from outside or UVA providers and can give informed consent. It's not suitable for prisoners.
What is being tested?
The study tests a new scoring system, the Orton Score, against typical standard care to improve bowel prep before outpatient colonoscopies. The goal is to reduce inadequate preps and increase polyp detection without randomizing patients.
What are the potential side effects?
While specific side effects aren't listed, bowel prep generally may cause discomfort such as cramping, bloating, nausea or vomiting. Extended prep might increase these sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was referred for a colonoscopy by another doctor.
Select...
I am between 18 and 100 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study duration, approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study duration, approximately 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Inadequate prep rate
Secondary study objectives
Adenoma detection rate (ADR)
Advanced adenoma / adenocarcinoma detection rate
Incomplete colonoscopy rate
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Retrospective Cohort (before Orton Score)Experimental Treatment1 Intervention
Group II: Orton Score Cohort - HighActive Control1 Intervention
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.
Group III: Prospective Orton Score Cohort - LowPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,225 Total Patients Enrolled
Steven M Powell, MDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was referred for a colonoscopy by another doctor.I am between 18 and 100 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Orton Score Cohort - High
- Group 2: Prospective Orton Score Cohort - Low
- Group 3: Retrospective Cohort (before Orton Score)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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