Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience

This study has been withdrawn prior to enrollment.
(Supply of adequate label was not provided to the MHRA)
Sponsor:
Information provided by:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT00460837
First received: March 23, 2007
Last updated: July 23, 2010
Last verified: July 2010

March 23, 2007
July 23, 2010
November 2007
Not Provided
  • 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) ]
  • versus standard bowel preparation
  • Patient experience and compliance with the reduced laxative tagging regimen
Complete list of historical versions of study NCT00460837 on ClinicalTrials.gov Archive Site
Comparison of per polyp specificity between the two preparation regimens [ Time Frame: 1 day (analysis time) ]
Comparison of per polyp specificity between the two preparation regimens.
Not Provided
Not Provided
 
Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience
Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Colorectal Cancer
Drug: bowel preparation: senna & gastrofin versus picolax (standard)
The intervention is a bowel cleansing procedure
  • Active Comparator: 1 A
    gastrofin & Picolax
    Intervention: Drug: bowel preparation: senna & gastrofin versus picolax (standard)
  • Active Comparator: 2
    senna
    Intervention: Drug: bowel preparation: senna & gastrofin versus picolax (standard)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
150
March 2009
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00460837
07.senna.SMH
Yes
Dr Alan Warnes, North West London Hospitals NHS Trust
London North West Healthcare NHS Trust
Not Provided
Principal Investigator: David Burling St Mark's Hospital, North West London Hospitals NHS Trust
London North West Healthcare NHS Trust
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP