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Completed

NCT Number: NCT02371655

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

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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Key information

Conditions

Cathartic Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICOT Hospital, Sapienza

Latina, 04100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Procedure

A low-fibre diet for three days before the examination

Other names: diet included

Faecal Tagging

Drug

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

Other names: iodinated contrast media (oral)

Bowel cleansing

Drug

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

Other names: chatartic bowel preparation

CT colonography

Procedure

CT Examination of the colon aimed to detect polyps and cancer

Other names: Virtual colonoscopy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Acronym: DIETSAN

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2015
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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