Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial

Study Overview
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Brief Summary
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The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.

Detailed Description
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Bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. For this reason, limited bowel preparations have been extensively investigated. Usually, they combine the use of low-fibre diet and faecal/fluid tagging. The ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. A low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Primary outcome is the overall quality of bowel preparation.

Official Title
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Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial

Conditions
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Cathartic Colon, Colonic Neoplasms

Intervention / Treatment
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* Procedure: Diet
* Drug: Faecal Tagging
* Drug: Bowel cleansing
* Procedure: CT colonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic patients (Screening Patients) Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients) Patients with a previous incomplete optical colonoscopy. Exclusion Criteria: Allergy to Macrogol Cognitive behavioral deficits

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet included<br>Diet is included in bowel preparation | Procedure: Diet<br>* A low-fibre diet for three days before the examination<br>* Other names: diet included;Drug: Faecal Tagging<br>* Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination<br>* Other names: iodinated contrast media (oral);Drug: Bowel cleansing<br>* Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination<br>* Other names: chatartic bowel preparation;Procedure: CT colonography<br>* CT Examination of the colon aimed to detect polyps and cancer<br>* Other names: Virtual colonoscopy;|
| Experimental: Diet not included<br>Diet is not included in bowel preparation | Drug: Faecal Tagging<br>* Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination<br>* Other names: iodinated contrast media (oral);Drug: Bowel cleansing<br>* Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination<br>* Other names: chatartic bowel preparation;Procedure: CT colonography<br>* CT Examination of the colon aimed to detect polyps and cancer<br>* Other names: Virtual colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension). | the evaluation of overall quality of bowel preparation on CT colonography images including: homogeneity of tagging, presence of unmarked solid stool residues, the evaluation of volume of residual fluids and colon distention. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance of patients | A 0-10 visual analogical scale (VAS) was used with 0 corresponding to no discomfort and 10 to severe discomfort with severe impact on patient's daily activities. Intermediate values corresponded to intermediate values of tolerance. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel cleansing, CTcolonography, Bowel preparation, Faecal and fluid tagging