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

July 23, 2010 updated by: London North West Healthcare NHS Trust

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlesex
      • London, Middlesex, United Kingdom, HA1 3UJ
        • St Mark's Hospital, North West London Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Versus standard bowel preparation
Time Frame: 1 day (while on regimen + effectivness analysis time)
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)
1 day (while on regimen)

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of per polyp specificity between the two preparation regimens
Time Frame: 1 day (analysis time)
1 day (analysis time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: David Burling, St Mark's Hospital, North West London Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (ANTICIPATED)

March 1, 2009

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (ESTIMATE)

April 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.senna.SMH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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