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

University of Roma La Sapienza

Status: Completed

Conditions: Cathartic Colon; Colonic Neoplasms

Treatments: Procedure: Diet; Drug: Faecal Tagging; Drug: Bowel cleansing; Procedure: CT colonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02371655

URomLSDBAL1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Diet included

Active Comparator group

Description:

Diet is included in bowel preparation

Treatment:

Procedure: CT colonography

Drug: Bowel cleansing

Drug: Faecal Tagging

Procedure: Diet

Diet not included

Experimental group

Description:

Diet is not included in bowel preparation

Treatment:

Procedure: CT colonography

Drug: Bowel cleansing

Drug: Faecal Tagging