Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212433
Status:
COMPLETED
Last Update Posted:
2006-07-24
First Post:
2005-09-12
Brief Title:
Optimisation and Performance of Reduced Preparation CT Colography
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
Multidetector-Row CT Colonography Optimisation of Reduced Bowel Preparation Regimes and Diagnostic Performance in Comparison to Colonoscopy
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None