Imaging Template for Reporting Anal Fistula

• Conditions: Anal Fistula

• Registration Number: NCT04541238
• Lead Sponsor: Treviso Regional Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Active cancer of the anorectum
• Recto-vaginal fistula

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors	60 days

Secondary Outcome Measures

Name	Time	Method
Inter-rater agreement between two independent experienced radiologists using the novel template	7 days
Qualitative analysis	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.

Trial Locations

Locations (1)

Treviso Regional Hospital; 🇮🇹 Treviso, Italy