Comparison of Bowel Preparation in Virtual Colonoscopy (VC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1 A

gastrofin \& Picolax

Group Type ACTIVE_COMPARATOR

bowel preparation: senna & gastrofin versus picolax (standard)

Intervention Type DRUG

The intervention is a bowel cleansing procedure

2

senna

Group Type ACTIVE_COMPARATOR

bowel preparation: senna & gastrofin versus picolax (standard)

Intervention Type DRUG

The intervention is a bowel cleansing procedure

Interventions

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bowel preparation: senna & gastrofin versus picolax (standard)

The intervention is a bowel cleansing procedure

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No