NCT02371655

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cathartic Colon
• Colonic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Diet	A low-fibre diet for three days before the examination
DRUG	Faecal Tagging	Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
DRUG	Bowel cleansing	Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
PROCEDURE	CT colonography	CT Examination of the colon aimed to detect polyps and cancer

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-02-25
• Last updated: 2017-05-12

Locations

1 site across 1 country: Italy