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

NCT07019532 | Not Yet Recruiting DMC

• 1 other identifier: FISTUL-ML-01
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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 identification of fistula development.

Conditions

Perianal Abscess; Anal Fistula

Keywords

Artificial Intelligence; MR Imaging; Colorectal Surgery; Surgical Outcomes; Drainage; Fistula Prediction

Outcome Measures

Primary Outcomes (1)

• Fistula formation within 6 months

  Confirmed by clinical exam, surgical findings, or MR imaging

  6 months

Secondary Outcomes (3)

• Correlation between drainage location and fistula rate

  6 months

• Correlation between provider experience and fistula complexity

  6 months

• Diagnostic accuracy of AI-based MR analysis vs radiologist

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Existing anal fistula history
• Crohn's disease
• Immunosuppressive treatment
• Incomplete 6-month follow-up

Sponsors & Collaborators

• Gumushane State Hospital: lead

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kayahan Eyüboğlu, MD

CONTACT

+905546813327; kayahaneyuboglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Specialist

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR