Imaging Template for Reporting Anal Fistula

Anal Fistula Clinical Trial

— ITRAF  

Official title:

Imaging Template for Reporting Anal Fistula

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04541238
• Other study ID #: ITRAF2020
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2020
• Source: Treviso Regional Hospital
• Contact: Ugo Grossi, PhD
• Phone: +393291649443
• Email: ugo.grossi[@]aulss2.veneto.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Active cancer of the anorectum

• Recto-vaginal fistula

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Diagnostic Test:
• MRI
Magnetic resonance imaging

Locations

Country	Name	City	State
Italy	Treviso Regional Hospital	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
Treviso Regional Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the novel template compared to standard reporting based on the number of key descriptors		60 days
Secondary	Inter-rater agreement between two independent experienced radiologists using the novel template		7 days
Secondary	Qualitative analysis	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