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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT02371655

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cathartic Colon Colonic Neoplasms	Procedure: Diet Drug: Faecal Tagging Drug: Bowel cleansing Procedure: CT colonography	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

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). [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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICOT Hospital, Sapienza	Latina		Italy	04100

Sponsors and Collaborators

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