Evaluation of Stool Tagging for Improved Patient Compliance

Status unconfirmed

Conditions studied: Colon Cancer, Polyps

In brief

Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. The investigator's prior work demonstrated that the bowel preparation was the least tolerable aspect of colorectal evaluation when compared to the CT colonography and optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel preparation, with fewer false positives due to retained stool-mimicking polyps. The researchers hypothesize that image quality and patient preference will vary with stool tagging concentration and dosing schedule. The researchers propose to evaluate specific stool tagging protocols with the following aims: AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal evaluation. AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across stool tagging protocols for the outcome measures of patient preference, image quality in the presence of tagging, and diagnostic reader performance. The researchers will use specific variations in stool tagging techniques to determine the best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest patient acceptability, as well as evaluate the adequacy of preparation for same-day colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat adenomas. Most importantly, these results will help inform the design of a larger trial of an optimized CT colonography technique in a community setting.

Key facts

Study ID

NCT00124163

Run by

Center for Diagnostic Imaging

People needed

60

Starts

2005-07-01

Last updated by the study team

2006-02-02

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients who are 45 to 80 years old for routine screening colonoscopy

You may not qualify if…

• Patients with inflammatory bowel disease
• Patients with polyposis syndromes
• Pregnant women
• Patients over 350 pounds
• Patients with bright red blood per rectum
• Patients who have a contraindication to undergo outpatient colonoscopy, including patients on blood thinners, prior myocardial infarction (MI) in the last six months, history of congestive heart failure (CHF), history of arrhythmia, patients too weak to transfer themselves from a bed to a chair, or patients with severe constipation who would require a two day bowel preparation.
• All subjects will undergo informed consent by the St. Luke's institutional review board (IRB). Referred subjects will be asked if they are interested in the study and those responding affirmatively will be transferred to a recruiter to learn about the study and begin the consent process if interested.

Where it is running

• Diagnostic Imaging Associates — Chesterfield, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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