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

May 11, 2017 updated by: Davide Bellini, University of Roma La Sapienza
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy, 04100
        • ICOT Hospital, Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diet included
Diet is included in bowel preparation
Procedure: Diet
A low-fibre diet for three days before the examination
Other Names:
  • diet included
Drug: Faecal Tagging
Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
Other Names:
  • iodinated contrast media (oral)
Drug: Bowel cleansing
Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
Other Names:
  • chatartic bowel preparation
Procedure: CT colonography
CT Examination of the colon aimed to detect polyps and cancer
Other Names:
  • Virtual colonoscopy
Experimental: Diet not included
Diet is not included in bowel preparation
Drug: Faecal Tagging
Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
Other Names:
  • iodinated contrast media (oral)
Drug: Bowel cleansing
Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
Other Names:
  • chatartic bowel preparation
Procedure: CT colonography
CT Examination of the colon aimed to detect polyps and cancer
Other Names:
  • Virtual colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compliance of patients
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: Laghi Andrea, Professor, University of Rome "Sapienza" Faculty of Medicine and Dentistry Department of Radiological Sciences, Oncology and Pathology I.C.O.T. - Via F. Faggiana 34, 04100 Latina, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URomLSDBAL1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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