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

Colonic Neoplasms Clinical Trial

— DIETSAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371655
• Other study ID #: URomLSDBAL1
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: May 11, 2017
• Start date: October 1, 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: May 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cathartic Colon
• Colonic Neoplasms

Intervention

Procedure:
• Diet
A low-fibre diet for three days before the examination

Drug:
• Faecal Tagging
Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
• Bowel cleansing
Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination

Procedure:
• CT colonography
CT Examination of the colon aimed to detect polyps and cancer

Locations

Country	Name	City	State
Italy	ICOT Hospital, Sapienza	Latina

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	1 day