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Imaging Template for Reporting Anal Fistula

Imaging Template for Reporting Anal Fistula

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04541238
Acronym
ITRAF
Enrollment
100
Registered
2020-09-09
Start date
2020-09-01
Completion date
2021-01-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Brief summary

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.

Interventions

DIAGNOSTIC_TESTMRI

Magnetic resonance imaging

Sponsors

Treviso Regional Hospital
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Active cancer of the anorectum * Recto-vaginal fistula

Design outcomes

Primary

MeasureTime frame
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors60 days

Secondary

MeasureTime frameDescription
Inter-rater agreement between two independent experienced radiologists using the novel template7 days
Qualitative analysis30 daysThe 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.

Countries

Italy

Contacts

Primary ContactUgo Grossi, PhD
ugo.grossi@aulss2.veneto.it+393291649443

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026