Perianal FistulaMRI PA fistulaNCT07510204
Role of MRI in Perianal Fistula
An observational study of Perianal Fistula, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the diagnostic accuracy of MRI in detecting and assessment the primary fistulous tract, internal openings, secondary extensions, and associated abscesses. (and compare these findings with the surgical findings in patients who underwent surgery). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- Diagnostic imaging (MRI)
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients clinically suspected or diagnosed with perianal fistula who are referred to the radiology department for preoperative MRI evaluation. The study will include both male and female patients of different age groups presenting to the surgical or colorectal clinics and scheduled for surgical management. MRI findings will be compared with intraoperative findings to assess diagnostic accuracy.
Who may be able to join
- Patients clinically diagnosed or suspected to have perianal fistula.
- Both male and female patients of any age group
- Patients referred for preoperative MRI assessment prior to surgical management.
Who cannot join
- Patients with contraindications to MRI, such as pacemakers, metallic implants, or severe claustrophobia.
- Patients refusing to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag, Sohag Governorate
Merit Nabil Sobhy, Resident, 01271935119, meret_nabil_post@med.sohag.edu.eg
Merit Nabil Sobhy, Resident
About this study
Official title: Role of Magnetic Resonance Imaging in Assessment of Perianal Fistula
The aim of this study is to assess the diagnostic accuracy of MRI in detecting and assessment the primary fistulous tract, internal openings, secondary extensions, and associated abscesses. (and compare these findings with the surgical findings in patients who underwent surgery).
Read the detailed description
This study aims to evaluate the diagnostic accuracy of magnetic resonance imaging (MRI) in the preoperative assessment of anal fistula. MRI has become an essential imaging modality for the evaluation of perianal fistulous disease due to its superior soft-tissue contrast and ability to delineate fistulous tracts, internal openings, secondary extensions, and associated abscesses.
Patients clinically suspected of having anal fistula and scheduled for surgical management will undergo preoperative MRI examination. The MRI protocol will include multiplanar T1-weighted and T2-weighted sequences, with or without fat suppression, to accurately identify the primary fistulous tract, internal opening, secondary ramifications, and any associated collections.
MRI findings will be recorded and classified according to standard fistula classification systems. These findings will then be compared with intraoperative surgical findings, which will be considered the reference standard.
The primary objective of this study is to determine the diagnostic accuracy of MRI in identifying the primary tract, internal opening, secondary extensions, and associated abscesses. Secondary objectives include assessing the role of MRI in preoperative planning and evaluating its ability to reduce recurrence rates through better delineation of fistulous anatomy.
The results of this study may contribute to improving preoperative evaluation strategies and optimizing surgical management in patients with perianal fistula.
- Conditions
- Perianal Fistula
- Being tested
- Diagnostic imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging (MRI)Other
MRI is performed as apart of peri-operative assessment of perianal fistula, This is not therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with perianal fistula | Participants clinically suspected to have perianal fistula and sent to MRI unit for peri-operative assessment of the Fistula. Receives: Other: Diagnostic imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of MRI in assessment of perianal fistula
Evaluation of the diagnostic accuracy of magnetic resonance imaging (MRI) in detecting and classifying perianal fistulas and associated complications. MRI findings will be compared with surgical findings as the reference standard to determine sensitivity, specificity, and overall diagnostic performance.
Measured: Preoperative MRI assessment performed within 2 weeks before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meret Nabil, Sohag University
- Investigators
- Nahla Mohamed Ali, MD, Principal investigator, unaffillated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510204
- Sponsor's protocol ID
- Soh-Med-26-3-6MS
- Acronym
- MRI PA fistula
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Magnetic Resonance Imaging in Assessment of Perianal Fistula
- ClinicalTrials.gov ID
- NCT07510204
- Acronym / sponsor ID
- MRI PA fistula / Soh-Med-26-3-6MS
- Conditions
- Perianal Fistula
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Apr 2026 (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.
The aim of this study is to assess the diagnostic accuracy of MRI in detecting and assessment the primary fistulous tract, internal openings, secondary extensions, and associated abscesses. (and compare these findings with the surgical findings in patients who underwent surgery).
Detailed description
This study aims to evaluate the diagnostic accuracy of magnetic resonance imaging (MRI) in the preoperative assessment of anal fistula. MRI has become an essential imaging modality for the evaluation of perianal fistulous disease due to its superior soft-tissue contrast and ability to delineate fistulous tracts, internal openings, secondary extensions, and associated abscesses.
Patients clinically suspected of having anal fistula and scheduled for surgical management will undergo preoperative MRI examination. The MRI protocol will include multiplanar T1-weighted and T2-weighted sequences, with or without fat suppression, to accurately identify the primary fistulous tract, internal opening, secondary ramifications, and any associated collections.
MRI findings will be recorded and classified according to standard fistula classification systems. These findings will then be compared with intraoperative surgical findings, which will be considered the reference standard.
The primary objective of this study is to determine the diagnostic accuracy of MRI in identifying the primary tract, internal opening, secondary extensions, and associated abscesses. Secondary objectives include assessing the role of MRI in preoperative planning and evaluating its ability to reduce recurrence rates through better delineation of fistulous anatomy.
The results of this study may contribute to improving preoperative evaluation strategies and optimizing surgical management in patients with perianal fistula.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with perianal fistula | – | Other: Diagnostic imaging (MRI)Participants clinically suspected to have perianal fistula and sent to MRI unit for peri-operative assessment of the Fistula. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients clinically suspected or diagnosed with perianal fistula who are referred to the radiology department for preoperative MRI evaluation. The study will include both male and female patients of different age groups presenting to the surgical or colorectal clinics and scheduled for surgical management. MRI findings will be compared with intraoperative findings to assess diagnostic accuracy.
Key inclusion criteria (3 listed)
- Patients clinically diagnosed or suspected to have perianal fistula.
- Both male and female patients of any age group
- Patients referred for preoperative MRI assessment prior to surgical management.
Key exclusion criteria (2 listed)
- Patients with contraindications to MRI, such as pacemakers, metallic implants, or severe claustrophobia.
- Patients refusing to participate in the study.
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 |
|---|---|---|
| Diagnostic imaging (MRI)MRI is performed as apart of peri-operative assessment of perianal fistula, This is not therapeutic intervention. | Other | Patients with perianal fistula |
Primary outcome
Diagnostic accuracy of MRI in assessment of perianal fistula
Time frame: Preoperative MRI assessment performed within 2 weeks before surgery.
Evaluation of the diagnostic accuracy of magnetic resonance imaging (MRI) in detecting and classifying perianal fistulas and associated complications. MRI findings will be compared with surgical findings as the reference standard to determine sensitivity, specificity, and overall diagnostic performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality considerations.
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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.
Nahla Mohamed Ali, MD principal investigator
unaffillated
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 Perianal Fistula, run by Sohag University at 1 site in Egypt.
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 3 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: opening soon, as of the sponsor's last update on 3 Apr 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merit Nabil Sobhy, Resident (01271935119, meret_nabil_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of MRI in assessment of perianal fistula (time frame: Preoperative MRI assessment performed within 2 weeks before surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.