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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-12-01

Brief Summary

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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.

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Detailed Description

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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

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Cathartic Colon Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Diet included

Diet is included in bowel preparation

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type PROCEDURE

A low-fibre diet for three days before the examination

Faecal Tagging

Intervention Type DRUG

Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination

Bowel cleansing

Intervention Type DRUG

Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination

CT colonography

Intervention Type PROCEDURE

CT Examination of the colon aimed to detect polyps and cancer

Diet not included

Diet is not included in bowel preparation

Group Type EXPERIMENTAL

Faecal Tagging

Intervention Type DRUG

Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination

Bowel cleansing

Intervention Type DRUG

Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination

CT colonography

Intervention Type PROCEDURE

CT Examination of the colon aimed to detect polyps and cancer

Interventions

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Diet

A low-fibre diet for three days before the examination

Intervention Type PROCEDURE

Faecal Tagging

Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination

Intervention Type DRUG

Bowel cleansing

Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination

Intervention Type DRUG

CT colonography

CT Examination of the colon aimed to detect polyps and cancer

Intervention Type PROCEDURE

Other Intervention Names

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diet included iodinated contrast media (oral) chatartic bowel preparation Virtual colonoscopy

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Davide Bellini

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laghi Andrea, Professor

Role: STUDY_DIRECTOR

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