Anal fistula

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ORPHA:228113K60.3
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24Active trials65Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Anal fistula (also known as fistula-in-ano) is an abnormal tunnel-like tract that forms between the inner lining of the anal canal and the skin near the anus. It most commonly develops as a consequence of a perianal abscess, where an infection in one of the small glands inside the anus spreads to form a collection of pus, which then drains or is surgically drained, leaving behind a persistent channel. The condition primarily affects the anorectal region and surrounding perianal soft tissues. Key symptoms include persistent or recurrent perianal discharge (which may be purulent or blood-tinged), pain around the anus that often worsens with sitting or bowel movements, swelling, skin irritation, and sometimes fever if secondary infection occurs. Patients may notice a visible external opening near the anus from which discharge drains. Anal fistulas can be classified based on their anatomical relationship to the anal sphincter muscles (intersphincteric, transsphincteric, suprasphincteric, or extrasphincteric). While most cases are cryptoglandular in origin, anal fistulas can also be associated with underlying conditions such as Crohn's disease, tuberculosis, radiation therapy, or prior pelvic surgery. The condition predominantly affects adults, with a higher incidence in males than females. Treatment is primarily surgical, as spontaneous healing is uncommon. Surgical options include fistulotomy (laying open the tract), seton placement (a thread or rubber band placed through the fistula to promote gradual drainage and healing), advancement flap procedures, ligation of the intersphincteric fistula tract (LIFT procedure), and fibrin glue or collagen plug insertion. The choice of procedure depends on the complexity and location of the fistula relative to the sphincter muscles, with the primary goal being to eradicate the fistula while preserving anal continence. Recurrence rates vary depending on fistula complexity and the surgical technique employed.

Clinical phenotype terms— hover any for plain English:

Anoperineal fistulaHP:0005218CellulitisHP:0100658Anal painHP:0500005ChillsHP:0025143
Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
May 2026Impact of Surgical Timing on Anal Fistula Outcomes

Assiut University

TrialNOT YET RECRUITING
Jan 2026Recurrence and Anal Fistula Patient Reported Outcomes Trial

National and Kapodistrian University of Athens

TrialRECRUITING
Dec 2025Determining the Effect of Education Given to Patients Undergoing Outpatient Anal Fistula Surgery

Muğla Sıtkı Koçman University — NA

TrialNOT YET RECRUITING
Dec 2025Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery

The Affiliated Hospital of Putian University — NA

TrialNOT YET RECRUITING
Dec 2025Effect of Platelet-Rich Plasma Injection on Wound Healing After Fistulotomy for Simple Anal Fistula Randomized Controlled Trial (RCT)

Assiut University — PHASE1

TrialNOT YET RECRUITING
Nov 2025TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

Cairo University — NA

TrialRECRUITING
Nov 2025Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas

ECM Therapeutics, Inc. — NA

TrialRECRUITING
Oct 2025Application Effects of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery

The Affiliated Hospital of Putian University — NA

TrialRECRUITING
Sep 2025A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose

Mayo Clinic — NA

TrialENROLLING BY INVITATION
Aug 2025Comparative Study: Fistula Rerouting vs. LIFT for High Perianal Fistula

Cairo University — NA

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Anal fistula.

20 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

20 recruitingView all trials with filters →
Phase 31 trial
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
Phase 3
Actively Recruiting
· Sites: Nanjing, Jiangsu · Age: 1870 yrs
Phase 21 trial
Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing
Phase 2
Active
PI: Alexander T Hawkins (Vanderbilt University Medical Center) · Sites: Nashville, Tennessee · Age: 2299 yrs
Phase 14 trials
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Phase 1
Actively Recruiting
PI: April Camilla Roslani, Prof. Dr. (Department of Surgery, Faculty of Medicine, Univer) · Sites: Kuala Lumpur · Age: 1899 yrs
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Phase 1
Actively Recruiting
PI: Jeffrey W Milsom, MD (Weill Medical College of Cornell University) · Sites: New York, New York · Age: 1899 yrs
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Phase 1
Actively Recruiting
· Sites: Guangzhou, Guangdong · Age: 1870 yrs
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Phase 1
Actively Recruiting
· Sites: Suzhou, Jiangsu · Age: 1870 yrs
N/A7 trials
Comparative Study: Fistula Rerouting vs. LIFT for High Perianal Fistula
N/A
Actively Recruiting
· Sites: Cairo, Al-Manial Cairo · Age: 2065 yrs
TROPIS Versus Coring Out Fistulectomy in High Anal Fistula
N/A
Actively Recruiting
PI: Haitham M.Azmy Basiouny, Lecturer (Cairo University) · Sites: Cairo, Al-Manial Cairo · Age: 1899 yrs
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
N/A
Actively Recruiting
PI: Karin Gustafsson, MD (University Hospital, Umeå) · Sites: Umeå, County of Vasterbotten § · Age: 1899 yrs
Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.
N/A
Actively Recruiting
· Sites: Guangzhou, Guangdong · Age: 1860 yrs
Fistura® Procedure for the Treatment of Complex Anal Fistulas
N/A
Actively Recruiting
· Sites: Braine-l'Alleud · Age: 1899 yrs
Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
N/A
Actively Recruiting
· Sites: Saint-Denis; Saint-Denis · Age: 1899 yrs
BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
N/A
Actively Recruiting
PI: Jeffrey L Van Eps, MD (The University of Texas Health Science Center, Hou) · Sites: Houston, Texas · Age: 1899 yrs
Other6 trials
Patient's Quality of Life and Functional Changes After Fistula Surgery
Actively Recruiting
· Sites: Al Mansurah, Dakahlyia · Age: 1880 yrs
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Actively Recruiting
· Sites: Nantes · Age: 1899 yrs
Recurrence and Anal Fistula Patient Reported Outcomes Trial
Actively Recruiting
· Sites: Athens · Age: 1899 yrs
BioHealx® Anal Fistula Device Post Market Surveillance Study
Actively Recruiting
· Sites: Fort Myers, Florida; Bryn Mawr, Pennsylvania · Age: 1875 yrs
Myriad™ Augmented Soft Tissue Reconstruction Registry
Actively Recruiting
PI: Tracee Short, MD (Short Consulting Group, LLC) · Sites: Los Angeles, California; Fort Myers, Florida +11 more · Age: 1899 yrs
Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre
Active
· Sites: Paris · Age: 1899 yrs

Specialists

Showing 25 of 65View all specialists →
KS
Karam M Sørensen
Specialist
PI on 2 active trials31 Anal fistula publications
AM
Andreas M Kaiser, MD
DUARTE, CA
Specialist
PI on 1 active trial1 Anal fistula publication
MM
Michel Adamina, MD, PD, MSc
CLEVELAND, OH
Specialist
PI on 1 active trial2 Anal fistula publications
AD
April Camilla Roslani, Prof. Dr.
Specialist
PI on 1 active trial
JM
Jeffrey L Van Eps, MD
Specialist
PI on 1 active trial
TP
Tung-Cheng Chang, MD, PHD
Specialist
PI on 1 active trial
TP
Tung Cheng Chang, MD, PHD
Specialist
PI on 1 active trial
WM
Wael Khafagy, MD
Specialist
PI on 1 active trial1 Anal fistula publication
LM
Laurent Abramowitz, MD
Specialist
PI on 3 active trials1 Anal fistula publication
JM
Jeffrey W Milsom, MD
NEW YORK, NY
Specialist
PI on 1 active trial
QM
Qiang Meng
Specialist
PI on 1 active trial38 Anal fistula publications
SM
Sonja Diez, MD
Specialist
PI on 2 active trials
SF
sairah sadaf, fcps
Specialist
PI on 1 active trial
RM
Richard E Burney, MD
BIRMINGHAM, AL
Specialist
PI on 1 active trial
DS
Daniel Steinemann
Specialist
PI on 1 active trial16 Anal fistula publications
TP
Tungcheng Chang, MD, PHD
Specialist
PI on 1 active trial
GP
Gilberto Poggioli, Prof
Specialist
PI on 1 active trial
SM
Sameh Emile, M.D.
Specialist
PI on 4 active trials
BM
Barış Sevinç, M.D.
Specialist
PI on 2 active trials
NM
Nita M Kedar, M.S.(Ayu)
Specialist
PI on 2 active trials
BB
Brian Bressler
Specialist
PI on 1 active trial
DA
Donato F Altomare
Specialist
PI on 1 active trial
ZW
Zhen Jun Wang
Specialist
PI on 1 active trial
MS
Michael J Stamos
Specialist
PI on 1 active trial
AC
Adriana M Cadavid
HOPEWELL, NJ
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Anal fistula.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Anal fistula

Disease timeline:

New recruiting trial: Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Myriad™ Augmented Soft Tissue Reconstruction Registry

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Fistura® Procedure for the Treatment of Complex Anal Fistulas

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Tissue Therapy of Transsphincteric Anal Fistula

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Fistula-in-ano in Infants and Children

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Application Effects of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Recurrence and Anal Fistula Patient Reported Outcomes Trial

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: BioHealx® Anal Fistula Device Post Market Surveillance Study

A new clinical trial is recruiting patients for Anal fistula

New recruiting trial: Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

A new clinical trial is recruiting patients for Anal fistula

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

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Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Anal fistula

What is Anal fistula?

Anal fistula (also known as fistula-in-ano) is an abnormal tunnel-like tract that forms between the inner lining of the anal canal and the skin near the anus. It most commonly develops as a consequence of a perianal abscess, where an infection in one of the small glands inside the anus spreads to form a collection of pus, which then drains or is surgically drained, leaving behind a persistent channel. The condition primarily affects the anorectal region and surrounding perianal soft tissues. Key symptoms include persistent or recurrent perianal discharge (which may be purulent or blood-tinged)

At what age does Anal fistula typically begin?

Typical onset of Anal fistula is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Anal fistula?

Yes — 20 recruiting clinical trials are currently listed for Anal fistula on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Anal fistula?

25 specialists and care centers treating Anal fistula are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.