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Imaging Template for Reporting Anal Fistula (ITRAF)

T

Treviso Regional Hospital

Status

Unknown

Conditions

Anal Fistula

Treatments

Diagnostic Test: MRI

Study type

Observational

Funder types

NETWORK

Identifiers

NCT04541238
ITRAF2020

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Active cancer of the anorectum
  • Recto-vaginal fistula

Trial design

100 participants in 1 patient group

Novel template report
Description:
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.
Treatment:
Diagnostic Test: MRI

Trial contacts and locations

1

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Central trial contact

Ugo Grossi, PhD

Data sourced from clinicaltrials.gov

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