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Comparison of Bowel Preparation in VC - Patient Experience

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Diagnostic Active 18 and over Other 07.senna.SMH
NCT00460837

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Northwick Park Hospital

David Burling

Principal Investigator

David Burling		Ph: 0044208235 Ext.4182
		Email: burlingdavid@yahoo.co.uk

Rosemina Ahmad		Ph: 0044208235 Ext.4186
		Email: rosahmad@hotmail.com

Trial Sites

United Kingdom

London

St. Mark's Hospital

Alan Warnes Ph: 0044208 869 Ext.2011

Email: alan.warnes@nwlh.nhs.uk

Iva Hauptmannova Ph: 0044208 869 Ext.5023

Email: iva.hauptmannova@nwlh.nhs.uk

David Burling Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00460837
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.