Cathartic Colon, Colonic Neoplasms
Conditions
Keywords
Bowel cleansing, CTcolonography, Bowel preparation, Faecal and fluid tagging
Brief summary
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
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.
Interventions
PROCEDUREDiet
A low-fibre diet for three days before the examination
DRUGFaecal Tagging
Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
DRUGBowel cleansing
Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
PROCEDURECT colonography
CT Examination of the colon aimed to detect polyps and cancer
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compliance of patients | 1 day | 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. |
Countries
Italy
Outcome results
None listed