Clinical trial NCT02371655: Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
Official title: Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cathartic Colon
Colonic Neoplasms
Keywords: Bowel cleansing
CTcolonography
Bowel preparation
Faecal and fluid tagging
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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).
timeFrame: 1 day
Secondary outcomes:
measure: compliance of patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Latina
country: Italy
facility: ICOT Hospital, Sapienza
Study officials:
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
name: Laghi Andrea, Professor
role: STUDY_DIRECTOR
References:
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.
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.