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

Study Overview
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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.

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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: bowel preparation: senna & gastrofin versus picolax (standard)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 A<br>gastrofin & Picolax | Drug: bowel preparation: senna & gastrofin versus picolax (standard)<br>* The intervention is a bowel cleansing procedure<br>|
| Active Comparator: 2<br>senna | Drug: bowel preparation: senna & gastrofin versus picolax (standard)<br>* The intervention is a bowel cleansing procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, bowel preparation regimen, patients with symptoms attributable to colorectal cancer