NCT02371655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

February 19, 2015

Last Update Submit

May 11, 2017

Conditions

Cathartic ColonColonic Neoplasms

Keywords

Bowel cleansingCTcolonographyBowel preparationFaecal and fluid tagging

Outcome Measures

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).

    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 Outcomes (1)

  • compliance of patients

    1 day

Study Arms (2)

Diet included

ACTIVE COMPARATOR

Diet is included in bowel preparation

Procedure: DietDrug: Faecal TaggingDrug: Bowel cleansingProcedure: CT colonography

Diet not included

EXPERIMENTAL

Diet is not included in bowel preparation

Drug: Faecal TaggingDrug: Bowel cleansingProcedure: CT colonography

Interventions

DietPROCEDURE

A low-fibre diet for three days before the examination

Also known as: diet included
Diet included
Faecal TaggingDRUG

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

Also known as: iodinated contrast media (oral)
Diet includedDiet not included
Bowel cleansingDRUG

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

Also known as: chatartic bowel preparation
Diet includedDiet not included
CT colonographyPROCEDURE

CT Examination of the colon aimed to detect polyps and cancer

Also known as: Virtual colonoscopy
Diet includedDiet not included

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic patients (Screening Patients)
  • Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients)
  • Patients with a previous incomplete optical colonoscopy.

You may not qualify if:

  • Allergy to Macrogol
  • Cognitive behavioral deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICOT Hospital, Sapienza

Latina, 04100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 20566777BACKGROUND

  • 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.

    PMID: 25149295BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Diet

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

IT(1)