An observational study in Perianal Abscess and Anal Fistula, sponsored by Gumushane State Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Gumushane State Hospital · Observational
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.
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.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 450 is above the median of 85 across 46 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →This is the only study on the registry with Gumushane State Hospital as lead sponsor.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fistula formation within 6 months
Confirmed by clinical exam, surgical findings, or MR imaging
Time frame: 6 months
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
No study locations are listed for this record.
Plan to share: Yes — De-identified MR images and anonymized patient-level data will be available for collaborative analysis upon request.
Supporting information: Study protocol, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Dec 2025, 5 months later.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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