ClinicalTrials.Veeva

Menu

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

G

Gumushane State Hospital

Status

Begins enrollment this month

Conditions

Perianal Abscess
Anal Fistula

Study type

Observational

Funder types

Other

Identifiers

NCT07019532
FISTUL-ML-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

Loading...

Central trial contact

Kayahan Eyüboğlu, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems