Imaging Template for Reporting Anal Fistula (ITRAF)

September 1, 2020 updated by: Ugo Grossi, Treviso Regional Hospital

Magnetic resonance imaging (MRI) is the most used diagnostic tool for pre-operative assessment of anal fistula.

However, there is lack of standardization in reporting this investigation. Moreover, reports may miss a number of key information for surgical planning.

The aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Treviso, Italy
        • Treviso Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 MRI investigations for anal fistula.

Description

Inclusion Criteria:

  • Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI

Exclusion Criteria:

  • Active cancer of the anorectum
  • Recto-vaginal fistula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Novel template report

The last 100 consecutive and anonymized MRI investigations for primary perianal fistula reported according to standard practice by dedicated radiologists (the last 10 reports from each of 10 international centers) are reviewed blindly and independently by two experienced radiologists (based on case load, years of experience and publications on anal fistula) using a novel template incorporating 8 key descriptors.

A third independent experienced radiologist will resolve any disagreement and assess the presence of descriptors in the original report compared to the novel template.
Diagnostic test: MRI
Magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-rater agreement between two independent experienced radiologists using the novel template
Time Frame: 7 days
7 days
Qualitative analysis
Time Frame: 30 days
The 100 MRI investigations (100 original reports and 100 using the novel template) are sent to 20 experienced surgeons (10 randomly selected reports per surgeon, of which 5 reported conventionally and 5 using the novel template), who will complete a semistructured e-mail interview to collect in-depth information about any barriers and facilitators to implementation of the novel template, and ultimately explore surgical decision making.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Treviso Regional Hospital

Investigators

  • Principal Investigator: Ugo Grossi, PhD, Treviso Regional Hospital, University of Padua

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

January 31, 2021

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (ACTUAL)

September 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITRAF2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD are available on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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