Imaging Template for Reporting Anal Fistula

NCT ID: NCT04541238

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Anal Fistula

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

MRI

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging

Interventions

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MRI

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Active cancer of the anorectum
* Recto-vaginal fistula
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Treviso Regional Hospital

NETWORK

Sponsor Role lead

Responsible Party

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Ugo Grossi

Colorectal Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ugo Grossi, PhD

Role: PRINCIPAL_INVESTIGATOR

Treviso Regional Hospital, University of Padua

Locations

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Treviso Regional Hospital

Treviso, , Italy

Site Status

Countries

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Italy

Central Contacts

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Ugo Grossi, PhD

Role: CONTACT

+393291649443

References

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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.

Reference Type DERIVED
PMID: 33400032 (View on PubMed)

Other Identifiers

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ITRAF2020

Identifier Type: -

Identifier Source: org_study_id

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