Optimisation and Performance of Reduced Preparation CT Colography

This study has been completed.
Sponsor:
Collaborator:
St Mark's Foundation
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00212433
First received: September 12, 2005
Last updated: July 20, 2006
Last verified: December 2005
  Purpose

To ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography


Condition Intervention Phase
Patients With Potential Colorectal Neoplasia
Drug: Tagitol V, Lo So, Readi-Cat 2
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multidetector-Row CT Colonography: Optimisation of Reduced Bowel Preparation Regimes and Diagnostic Performance in Comparison to Colonoscopy

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • Which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography

Secondary Outcome Measures:
  • to compare the diagnostic performance of CT colonography after reduced bowel preparation and faecal tagging with conventional colonoscopy in patients undergoing both procedures

Estimated Enrollment: 120
Study Start Date: July 2004
Estimated Study Completion Date: February 2006
Detailed Description:

CT colonography has been shown to be accurate in detection of colorectal neoplasia in enriched patient populations and is generally preferred by patients to conventional endoscopy and barium enema. It is advocated as an acceptable alternative for colorectal cancer screening and is increasingly used in the investigation of symptomatic patients. Ideally, like conventional colonoscopy, CT colonography requires a clean colon, free of residual stool and fluid. There is however good evidence that the arduous bowel purgation regimes required may produce adverse effects such as electrolyte imbalance, and are more detrimental to overall patient experience and compliance than any subsequent investigation. An ability to perform CT colonography with reduced bowel purgation, whilst maintaining acceptable diagnostic accuracy, would undoubtedly make the technique a more attractive proposition both for population screening and investigation of symptomatic patients.

Interest has been generated in the use of orally ingested dilute barium or ionated contrast medium prior ro CT colonography to "label" or "tag" residual fluid or faecal matter reduced laxative. Such oral contrast agents are highly attenuating to X-rays such that labeled residual bowel contents appear white on CT scanning and are readily distinguished from true colonic pathology.

Despite the early promise of a few limited studies, there is no consensus as to the optimum oral contrast type, dose and concentration. Anecdotally barium tends to best label solid residue whereas iodinated contrast best labels fluid, but this assumption has not been proven. Furthermore it is known that iodinated contrast tends to draw fluid into the bowel, producing a wet colon, which may not be suited to CT colonography. However, this indrawing of fluid by iodinated contrast such as gastrograffin produces a mild laxative effect, which may obviate the need for further formal purgation.

The study aims to establish the optimum reduced preparation-tagging regimen, establish patient experience and document diagnostic performance compared to conventional colonoscopy.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are under investigation for suspected colonic neoplasia and over 50 years old:

    1. Symptomatic patients eg. change in bowel habit, rectal bleeding etc.
    2. Polyp surveillance
    3. Strong family history
    4. suspected neoplasia on previous investigation (e.g. barium enema)

Exclusion Criteria:

  • patients under 50 patients undergoing surveillance for inflammatory bowel disease (due to poor diagnostic use of CT colonography in this specific patient cohort)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212433

Locations
United Kingdom
St Mark's Hospital, North West London Hospitals NHS Trust
London, Middlesex, United Kingdom, HA1 3UJ
University College Hospital
London, United Kingdom, NW1 2BU
Oxford Radcliffe Hospital NHS Trust
Oxford, United Kingdom
Sponsors and Collaborators
North West London Hospitals NHS Trust
St Mark's Foundation
Investigators
Principal Investigator: Stuart Taylor, MD St Mark's Hospital, North West London NHS Trust; & University College Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00212433     History of Changes
Other Study ID Numbers: 04/Q0405/CT2
Study First Received: September 12, 2005
Last Updated: July 20, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
colorectal neoplasia
CT colonography
faecal tagging

ClinicalTrials.gov processed this record on September 18, 2014