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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00460837
• Other study ID #: 07.senna.SMH
• Status: Withdrawn
• Phase: Phase 4
• First received: March 23, 2007
• Last updated: July 23, 2010
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2010
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 150
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bowel preparation: senna & gastrofin versus picolax (standard)
The intervention is a bowel cleansing procedure

Locations

Country	Name	City	State
United Kingdom	St Mark's Hospital, North West London Hospitals NHS Trust	London	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Versus standard bowel preparation		1 day (while on regimen + effectivness analysis time)
Primary	Patient experience and compliance with reduced laxative tagging versus standard preparation		1 day (while on regimen)
Secondary	Comparison of per polyp specificity between the two preparation regimens		1 day (analysis time)