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

Phase 4

Withdrawn

• Conditions: Colorectal Cancer

• Registration Number: NCT00460837
• Lead Sponsor: London North West Healthcare NHS Trust

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.

Study Timeline

• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-04-16
• Study First Posted: 2007-04-17
• Study Start: 2007-11
• Study Completion: 2009-03
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-23
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Versus standard bowel preparation	1 day (while on regimen + effectivness analysis time)
Patient experience and compliance with reduced laxative tagging versus standard preparation	1 day (while on regimen)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St Mark's Hospital, North West London Hospitals NHS Trust; 🇬🇧 London, Middlesex, United Kingdom