Clinical trial NCT00460837: Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience
Official title: Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: colorectal cancer
bowel preparation regimen
patients with symptoms attributable to colorectal cancer
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2007-04-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Versus standard bowel preparation
timeFrame: 1 day (while on regimen + effectivness analysis time)
measure: Patient experience and compliance with reduced laxative tagging versus standard preparation
timeFrame: 1 day (while on regimen)
Secondary outcomes:
measure: Comparison of per polyp specificity between the two preparation regimens
timeFrame: 1 day (analysis time)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mark's Hospital, North West London Hospitals NHS Trust
state: Middlesex
Study officials:
affiliation: St Mark's Hospital, North West London Hospitals NHS Trust
name: David Burling
role: PRINCIPAL_INVESTIGATOR
References: