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

Primary Purpose

Cathartic Colon, Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diet
Faecal Tagging
Bowel cleansing
CT colonography
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cathartic Colon focused on measuring Bowel cleansing, CTcolonography, Bowel preparation, Faecal and fluid tagging

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • ICOT Hospital, Sapienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diet included

Diet not included

Arm Description

Diet is included in bowel preparation

Diet is not included in bowel preparation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 19, 2015
Last Updated
May 11, 2017
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02371655
Brief Title
Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
Acronym
DIETSAN
Official Title
Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cathartic Colon, Colonic Neoplasms
Keywords
Bowel cleansing, CTcolonography, Bowel preparation, Faecal and fluid tagging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet included
Arm Type
Active Comparator
Arm Description
Diet is included in bowel preparation
Arm Title
Diet not included
Arm Type
Experimental
Arm Description
Diet is not included in bowel preparation
Intervention Type
Procedure
Intervention Name(s)
Diet
Other Intervention Name(s)
diet included
Intervention Description
A low-fibre diet for three days before the examination
Intervention Type
Drug
Intervention Name(s)
Faecal Tagging
Other Intervention Name(s)
iodinated contrast media (oral)
Intervention Description
Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
Intervention Type
Drug
Intervention Name(s)
Bowel cleansing
Other Intervention Name(s)
chatartic bowel preparation
Intervention Description
Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
Intervention Type
Procedure
Intervention Name(s)
CT colonography
Other Intervention Name(s)
Virtual colonoscopy
Intervention Description
CT Examination of the colon aimed to detect polyps and cancer
Primary Outcome Measure Information:
Title
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).
Description
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 Outcome Measure Information:
Title
compliance of patients
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laghi Andrea, Professor
Organizational Affiliation
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
Official's Role
Study Director
Facility Information:
Facility Name
ICOT Hospital, Sapienza
City
Latina
ZIP/Postal Code
04100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20566777
Citation
Liedenbaum MH, Denters MJ, de Vries AH, van Ravesteijn VF, Bipat S, Vos FM, Dekker E, Stoker J. Low-fiber diet in limited bowel preparation for CT colonography: Influence on image quality and patient acceptance. AJR Am J Roentgenol. 2010 Jul;195(1):W31-7. doi: 10.2214/AJR.09.3572.
Results Reference
background
PubMed Identifier
25149295
Citation
Iafrate F, Iannitti M, Ciolina M, Baldassari P, Pichi A, Laghi A. Bowel cleansing before CT colonography: comparison between two minimal-preparation regimens. Eur Radiol. 2015 Jan;25(1):203-10. doi: 10.1007/s00330-014-3345-0. Epub 2014 Aug 23.
Results Reference
background

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

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