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

University of Roma La Sapienza100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

100

Conditions

Cathartic Colon Colonic Neoplasms

Interventions

DietPROCEDURE

A low-fibre diet for three days before the examination

Faecal TaggingDRUG

Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination

Bowel cleansingDRUG

Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ICOT Hospital, Sapienza

Latina, Italy

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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