Machine Learning-Based Risk Stratification for Fistula Formation After Perianal Abscess Drainage

NCT ID: NCT07019532

Last Updated: 2025-06-13

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

NOT_YET_RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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

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Perianal Abscess Anal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* First-time perianal abscess
* Surgical drainage performed

Exclusion Criteria

* Existing anal fistula history
* Crohn's disease
* Immunosuppressive treatment
* Incomplete 6-month follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gumushane State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kayahan Eyüboğlu

General Surgery Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Kayahan Eyüboğlu, MD

Role: CONTACT

+905546813327

Other Identifiers

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FISTUL-ML-01

Identifier Type: -

Identifier Source: org_study_id

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