Imaging Template for Reporting Anal Fistula
ITRAF
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedSeptember 9, 2020
September 1, 2020
4 months
September 1, 2020
September 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors
60 days
Secondary Outcomes (2)
Inter-rater agreement between two independent experienced radiologists using the novel template
7 days
Qualitative analysis
30 days
Study Arms (1)
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.
Interventions
Eligibility Criteria
100 MRI investigations for anal fistula.
You may qualify if:
- Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI
You may not qualify if:
- Active cancer of the anorectum
- Recto-vaginal fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Treviso Regional Hospital
Treviso, Italy
Related Publications (1)
Sudol-Szopinska I, Santoro GA, Kolodziejczak M, Wiaczek A, Grossi U. Magnetic resonance imaging template to standardize reporting of anal fistulas. Tech Coloproctol. 2021 Mar;25(3):333-337. doi: 10.1007/s10151-020-02384-6. Epub 2021 Jan 5.
PMID: 33400032DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ugo Grossi, PhD
Treviso Regional Hospital, University of Padua
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Colorectal Surgeon
Study Record Dates
First Submitted
September 1, 2020
First Posted
September 9, 2020
Study Start
September 1, 2020
Primary Completion
December 31, 2020
Study Completion
January 31, 2021
Last Updated
September 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
IPD are available on request