- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07510204
Role of MRI in Perianal Fistula (MRI PA fistula)
Role of Magnetic Resonance Imaging in Assessment of Perianal Fistula
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Merit Nabil Sobhy, Resident
- Phone Number: 01271935119
- Email: meret_nabil_post@med.sohag.edu.eg
Study Locations
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-
Sohag Governorate
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Sohag, Sohag Governorate, Egypt
- Sohag University Hospital
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Contact:
- Merit Nabil Sobhy, Resident
- Phone Number: 01271935119
- Email: meret_nabil_post@med.sohag.edu.eg
-
Principal Investigator:
- Merit Nabil Sobhy, Resident
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with contraindications to MRI, such as pacemakers, metallic implants, or severe claustrophobia.
- Patients refusing to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with perianal fistula
Participants clinically suspected to have perianal fistula and sent to MRI unit for peri-operative assessment of the Fistula.
|
MRI is performed as apart of peri-operative assessment of perianal fistula, This is not therapeutic intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative MRI assessment performed within 2 weeks before surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nahla Mohamed Ali, MD, unaffillated
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-3-6MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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