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Clinical Trials/NCT00460837
NCT00460837
Withdrawn
Phase 4

Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study

London North West Healthcare NHS Trust1 site in 1 country150 target enrollmentNovember 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
London North West Healthcare NHS Trust
Enrollment
150
Locations
1
Primary Endpoint
Versus standard bowel preparation
Status
Withdrawn
Last Updated
15 years ago

Overview

Brief Summary

The study will compare patient's 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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
March 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • patients with symptoms attributable to colorectal cancer

Exclusion Criteria

  • patients with known colorectal cancer referred for staging VC
  • patients who take laxatives regularly or with previous inadequate colonic examination due to excessive faecal residue
  • patients deemed too frail to undergo full bowel preparation

Outcomes

Primary Outcomes

Versus standard bowel preparation

Time Frame: 1 day (while on regimen + effectivness analysis time)

Patient experience and compliance with reduced laxative tagging versus standard preparation

Time Frame: 1 day (while on regimen)

Secondary Outcomes

  • Comparison of per polyp specificity between the two preparation regimens(1 day (analysis time))

Study Sites (1)

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