Perianal AbscessPRISMNCT07019532
Machine Learning-Based Risk Stratification for Fistula Formation After Perianal Abscess Drainage
An observational study of Perianal Abscess and Anal Fistula, run by Gumushane State Hospital.
Trial summary
This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Abscess, Anal Fistula
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jun 2026
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years old) undergoing surgical drainage for their first perianal abscess at a university or state hospital. Participants must not have a history of anal fistula, Crohn's disease, or be under immunosuppressive therapy. Follow-up duration is 6 months after drainage.
Who may be able to join
- Age ≥ 18
- First-time perianal abscess
- Surgical drainage performed
Who cannot join
- Existing anal fistula history
- Crohn's disease
- Immunosuppressive treatment
- Incomplete 6-month follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Cohort Study for Machine Learning-Based Prediction of Anal Fistula Formation After Perianal Abscess Drainage Based on Drainage Setting, Provider Experience, and MRI Interpretation (PRISM)
This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.
Read the detailed description
Perianal abscess drainage is a common surgical procedure. However, subsequent fistula formation remains a significant complication. This study aims to determine whether the procedure setting (operating room, emergency department, or outpatient clinic) and the experience level of the performing clinician affect fistula development rates.
Furthermore, the study evaluates the use of AI-assisted analysis of selected MR images to identify early signs of fistula formation. Selected image slices will be labeled based on radiological reports, and a machine learning model will be trained to predict fistula risk. The study will also compare AI-generated interpretations with expert radiologist assessments to validate performance.
The ultimate goal is to create a risk stratification tool to support clinical decision-making in surgical management of perianal abscesses.
- Conditions
- Perianal Abscess, Anal Fistula
- Keywords
- Artificial Intelligence, MR Imaging, Colorectal Surgery, Surgical Outcomes, Drainage, Fistula Prediction
- Medical subject headings
- Rectal Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula formation within 6 months
Confirmed by clinical exam, surgical findings, or MR imaging
Measured: 6 months
Secondary outcomes (3)
Correlation between drainage location and fistula rate
Measured: 6 months
Correlation between provider experience and fistula complexity
Measured: 6 months
Diagnostic accuracy of AI-based MR analysis vs radiologist
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal AbscessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gumushane State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kayahan Eyüboğlu, Gumushane State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019532
- Sponsor's protocol ID
- FISTUL-ML-01
- Acronym
- PRISM
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified MR images and anonymized patient-level data will be available for collaborative analysis upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study for Machine Learning-Based Prediction of Anal Fistula Formation After Perianal Abscess Drainage Based on Drainage Setting, Provider Experience, and MRI Interpretation (PRISM)
- ClinicalTrials.gov ID
- NCT07019532
- Acronym / sponsor ID
- PRISM / FISTUL-ML-01
- Conditions
- Perianal Abscess, Anal Fistula
- Keywords
- Artificial Intelligence, MR Imaging, Colorectal Surgery, Surgical Outcomes, Drainage, Fistula Prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Gumushane State HospitalOther government
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.
Detailed description
Perianal abscess drainage is a common surgical procedure. However, subsequent fistula formation remains a significant complication. This study aims to determine whether the procedure setting (operating room, emergency department, or outpatient clinic) and the experience level of the performing clinician affect fistula development rates.
Furthermore, the study evaluates the use of AI-assisted analysis of selected MR images to identify early signs of fistula formation. Selected image slices will be labeled based on radiological reports, and a machine learning model will be trained to predict fistula risk. The study will also compare AI-generated interpretations with expert radiologist assessments to validate performance.
The ultimate goal is to create a risk stratification tool to support clinical decision-making in surgical management of perianal abscesses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) undergoing surgical drainage for their first perianal abscess at a university or state hospital. Participants must not have a history of anal fistula, Crohn's disease, or be under immunosuppressive therapy. Follow-up duration is 6 months after drainage.
Key inclusion criteria (3 listed)
- Age ≥ 18
- First-time perianal abscess
- Surgical drainage performed
Key exclusion criteria (4 listed)
- Existing anal fistula history
- Crohn's disease
- Immunosuppressive treatment
- Incomplete 6-month follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fistula formation within 6 months
Time frame: 6 months
Confirmed by clinical exam, surgical findings, or MR imaging
3 secondary outcomes
Correlation between drainage location and fistula rate
Time frame: 6 months
Correlation between provider experience and fistula complexity
Time frame: 6 months
Diagnostic accuracy of AI-based MR analysis vs radiologist
Time frame: 6 months
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 13 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified MR images and anonymized patient-level data will be available for collaborative analysis upon 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Perianal Abscess and Anal Fistula, run by Gumushane State Hospital.
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 4 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Kayahan Eyüboğlu, MD (+905546813327, kayahaneyuboglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula formation within 6 months (time frame: 6 months). 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 13 Jun 2025.