Evaluation of Stool Tagging for Improved Patient Compliance

NCT00124163 | Unknown

• 1 other identifier: 633
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Polyps

Keywords

CT Virtual Colonoscopy; Optical Colonoscopy; Stool Tagging; Patient Preparation

Interventions

Imaging procedure of CT colonography PROCEDURE

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Center for Diagnostic Imaging: lead

Study Sites (1)

Diagnostic Imaging Associates

Chesterfield, Missouri, 63017, United States

RECRUITING

Related Publications (3)

• Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003 Dec 4;349(23):2191-200. doi: 10.1056/NEJMoa031618. Epub 2003 Dec 1.

  PMID: 14657426 BACKGROUND

• Iannaccone R, Laghi A, Catalano C, Mangiapane F, Lamazza A, Schillaci A, Sinibaldi G, Murakami T, Sammartino P, Hori M, Piacentini F, Nofroni I, Stipa V, Passariello R. Computed tomographic colonography without cathartic preparation for the detection of colorectal polyps. Gastroenterology. 2004 Nov;127(5):1300-11. doi: 10.1053/j.gastro.2004.08.025.

  PMID: 15520999 BACKGROUND

• Lefere PA, Gryspeerdt SS, Dewyspelaere J, Baekelandt M, Van Holsbeeck BG. Dietary fecal tagging as a cleansing method before CT colonography: initial results polyp detection and patient acceptance. Radiology. 2002 Aug;224(2):393-403. doi: 10.1148/radiol.2241011222.

  PMID: 12147834 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth G. McFarland, MD

  St. Luke's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth G. McFarland, MD

CONTACT

636-733-8911; McFarlandB@mir.wustl.edu

Elisabeth Quam-Berne

CONTACT

952-525-6308; lquam@cdirad.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2005
• First Posted: July 27, 2005
• Study Start: July 1, 2005
• Last Updated: February 2, 2006

Record last verified: 2006-01

Locations

US (1)