Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460837
Status:
WITHDRAWN
Last Update Posted:
2010-07-26
First Post:
2007-03-23
Brief Title:
Comparison of Bowel Preparation in Virtual Colonoscopy VC - Patient Experience
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
Virtual Colonoscopy Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study
Status:
WITHDRAWN
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Supply of adequate label was not provided to the MHRA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will compare patients experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue
Detailed Description:
Bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience potentially affecting compliance rates 1-3
Unlike existing whole colon investigations conventional colonoscopy and barium enema reduced laxative regimens can be successfully used with VC with the aim of improving patient experience whilst maintaining diagnostic accuracy These regimens utilize faecal tagging a method of labeling residual faeces and fluid with radiodense liquids such as iodine or barium based fluids which are taken orally by the patient Once faecal residue and fluid is labeled in this way it can easily be discriminated from true pathology which remains untagged
We are proposing to compare different bowel preparation regimens and ascertain patient experience of the different regimes while monitoring diagnostic accuracy of the 2 different regiments
Unlike existing whole colon investigations conventional colonoscopy and barium enema reduced laxative regimens can be successfully used with VC with the aim of improving patient experience whilst maintaining diagnostic accuracy These regimens utilize faecal tagging a method of labeling residual faeces and fluid with radiodense liquids such as iodine or barium based fluids which are taken orally by the patient Once faecal residue and fluid is labeled in this way it can easily be discriminated from true pathology which remains untagged
We are proposing to compare different bowel preparation regimens and ascertain patient experience of the different regimes while monitoring diagnostic accuracy of the 2 different regiments
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