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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I was referred for a colonoscopy by another doctor.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study duration, approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inadequate prep rate

Secondary outcome measures

Adenoma detection rate (ADR)

Advanced adenoma / adenocarcinoma detection rate

Incomplete colonoscopy rate

+1 more

Trial 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,531 Total Patients Enrolled

Steven M Powell, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Orton Score Clinical Trial Eligibility Overview. Trial Name: NCT04093557 — N/A

Colorectal Adenomas Research Study Groups: Orton Score Cohort - High, Prospective Orton Score Cohort - Low, Retrospective Cohort (before Orton Score)

Colorectal Adenomas Clinical Trial 2023: Orton Score Highlights & Side Effects. Trial Name: NCT04093557 — N/A

Orton Score 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093557 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for new participants in this trial?

"According to clinicaltrials.gov, this trial is no longer actively seeking participants; the listing was first created on January 1st 2023 and last updated on May 23rd 2022. However, 191 other studies are currently enrolling patients at this time."

Answered by AI

Are there any age constraints on the participants of this clinical trial?

"This study is open to patients between 18 and 100 years of age. Additionally, 8 trials designed for minors are available as well as 187 clinical studies aimed at individuals over 65 years old."

Answered by AI

What criteria must an individual fulfill to be eligible for this clinical investigation?

"The medical study is in search of 500 people between 18 and 100 years old with colonic polyps. To be eligible, potential participants must meet the age criteria (18 to 100) as well as having been referred for a colonoscopy from an outside or internal provider."

Answered by AI

Recent research and studies

Gastrointestinal EndoscopyJournal

The Impact of Suboptimal Bowel Preparation on Adenoma Miss Rates and the Factors Associated with Early Repeat Colonoscopy

Lebwohl, Benjamin, Fay Kastrinos, Michael Glick, Adam J. Rosenbaum, Timothy Wang, and Alfred I. Neugut. 2011. “The Impact of Suboptimal Bowel Preparation on Adenoma Miss Rates and the Factors Associated with Early Repeat Colonoscopy”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2011.01.051.

Gastrointestinal EndoscopyJournal

Effective Bowel Cleansing Before Colonoscopy: A Randomized Study of Split-dosage Versus Non-split Dosage Regimens of High-volume Versus Low-volume Polyethylene Glycol Solutions

Marmo, Riccardo, Gianluca Rotondano, Giovanni Riccio, Armando Marone, Maria Antonia Bianco, Italo Stroppa, Anna Caruso, et al.. 2010. “Effective Bowel Cleansing Before Colonoscopy: A Randomized Study of Split-dosage Versus Non-split Dosage Regimens of High-volume Versus Low-volume Polyethylene Glycol Solutions”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2010.02.048.

GastroenterologyJournal

Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations from the US Multi-society Task Force on Colorectal Cancer

Johnson, David A., Alan N. Barkun, Larry B. Cohen, Jason A. Dominitz, Tonya Kaltenbach, Myriam Martel, Douglas J. Robertson, et al.. 2014. “Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations from the US Multi-society Task Force on Colorectal Cancer”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2014.07.002.

Gastrointestinal EndoscopyJournal