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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This study has been withdrawn prior to enrollment.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:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00460837
First received: March 23, 2007
Last updated: July 23, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Drug: bowel preparation: senna & gastrofin versus picolax (standard)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Comparison of per polyp specificity between the two preparation regimens [ Time Frame: 1 day (analysis time) ]

Estimated Enrollment: 150
Study Start Date: November 2007
Estimated Study Completion Date: March 2009
Arms Assigned Interventions
Active Comparator: 1 A
gastrofin & Picolax
 Drug: bowel preparation: senna & gastrofin versus picolax (standard)
The intervention is a bowel cleansing procedure
Active Comparator: 2
senna
 Drug: bowel preparation: senna & gastrofin versus picolax (standard)
The intervention is a bowel cleansing procedure

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460837

Locations
United Kingdom
St Mark's Hospital, North West London Hospitals NHS Trust
London, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
North West London Hospitals NHS Trust
Investigators
Principal Investigator: David Burling St Mark's Hospital, North West London Hospitals NHS Trust
  More Information

Additional Information:
Official Hospital Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Alan Warnes, North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00460837     History of Changes
Other Study ID Numbers: 07.senna.SMH
Study First Received: March 23, 2007
Last Updated: July 23, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by North West London Hospitals NHS Trust:
colorectal cancer
bowel preparation regimen
patients with symptoms attributable to colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013