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

Not Applicable

Completed

• Conditions: Cathartic Colon; Colonic Neoplasms
• Interventions: Procedure: Diet; Drug: Faecal Tagging; Drug: Bowel cleansing; Procedure: CT colonography

• Registration Number: NCT02371655
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Study Start: 2015-10-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet included	Bowel cleansing	Diet is included in bowel preparation
Diet included	CT colonography	Diet is included in bowel preparation
Diet included	Diet	Diet is included in bowel preparation
Diet included	Faecal Tagging	Diet is included in bowel preparation
Diet not included	Faecal Tagging	Diet is not included in bowel preparation
Diet not included	Bowel cleansing	Diet is not included in bowel preparation
Diet not included	CT colonography	Diet is not included in bowel preparation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

ICOT Hospital, Sapienza; 🇮🇹 Latina, Italy