Anal FistulaITRAFNCT04541238
Imaging Template for Reporting Anal Fistula
An observational study of Anal Fistula, run by Treviso Regional Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- MRI
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 MRI investigations for anal fistula.
Who may be able to join
- Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI
Who cannot join
- Active cancer of the anorectum
- Recto-vaginal fistula
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anal Fistula
- Being tested
- MRI
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors
Measured: 60 days
Secondary outcomes (2)
Inter-rater agreement between two independent experienced radiologists using the novel template
Measured: 7 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treviso Regional Hospital
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ugo Grossi, Treviso Regional Hospital
- Investigators
- Ugo Grossi, PhD, Principal investigator, Treviso Regional Hospital, University of Padua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541238
- Sponsor's protocol ID
- ITRAF2020
- Acronym
- ITRAF
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD are available on request
Publications
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.
PubMed 33400032
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Template for Reporting Anal Fistula
- ClinicalTrials.gov ID
- NCT04541238
- Acronym / sponsor ID
- ITRAF / ITRAF2020
- Conditions
- Anal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Treviso Regional HospitalResearch network
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel template report | – | Diagnostic Test: MRIThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 MRI investigations for anal fistula.
Key inclusion criteria (1 listed)
- Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI
Key exclusion criteria (2 listed)
- Active cancer of the anorectum
- Recto-vaginal fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMagnetic resonance imaging | Diagnostic test | Novel template report |
Primary outcome
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors
Time frame: 60 days
2 secondary outcomes
Inter-rater agreement between two independent experienced radiologists using the novel template
Time frame: 7 days
Qualitative analysis
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 33400032Sudol-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.
- Individual participant dataSharing planned: Yes. IPD are available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugo Grossi, PhD principal investigator
Treviso Regional Hospital, University of Padua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Treviso Regional Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ugo Grossi, PhD (+393291649443, ugo.grossi@aulss2.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04541238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.