Anal fistula
diseaseOn this page
Also known as anal fistula (disease)anorectal fistula
Summary
Anal fistula (MONDO:0000754) is a disease and 98 clinical trials. Top therapeutic interventions include darvadstrocel, phenytoin, and clindamycin. A subtype of rectal disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Prevalence: 1-5 / 10 000 (Europe) [Orphanet-validated]
- Phenotypes (HPO): 7
- Clinical trials: 98
Clinical features
Epidemiology
Prevalence records
2 prevalence record(s), Orphanet:
| Type | Class | Value | Geography | Validation |
|---|---|---|---|---|
| Point prevalence | 1-5 / 10 000 | 18.3 | Europe | Validated |
| Point prevalence | 1-5 / 10 000 | 18 | United Kingdom | Validated |
Signs & symptoms
Clinical features (HPO)
7 HPO clinical features (Orphanet curated; top 7 by frequency):
| HPO ID | Term | Frequency |
|---|---|---|
| HP:0005218 | Anoperineal fistula | Very frequent (80-99%) |
| HP:0000989 | Pruritus | Frequent (30-79%) |
| HP:0100658 | Cellulitis | Frequent (30-79%) |
| HP:0500005 | Anal pain | Frequent (30-79%) |
| HP:0001974 | Leukocytosis | Occasional (5-29%) |
| HP:0001945 | Fever | Very rare (<1-4%) |
| HP:0025143 | Chills | Very rare (<1-4%) |
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | anal fistula |
| Mondo ID | MONDO:0000754 |
| MeSH | D012003 |
| Orphanet | 228113 |
| DOID | DOID:0060328 |
| ICD-10-CM | K60.3 |
| ICD-11 | 206903882 |
| NCIT | C60785 |
| SNOMED CT | 72779005 |
| UMLS | C0205929 |
| MedGen | 61482 |
| GARD | 0020568 |
| Is cancer (heuristic) | no |
Also known as: anal fistula · anal fistula (disease) · anorectal fistula
Data availability: 1 HPO phenotype.
Disease family
This is a subtype of rectal disorder. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by body system or component › digestive system disorder › intestinal disorder › large intestine disorder › rectal disorder › anal fistula
Related subtypes (5): ulcer of anus and rectum, rectal neoplasm, anus disorder, rectal prolapse, polyp of rectum
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated for this disease
1 approved. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.
| Drug | Development status |
|---|---|
| Darvadstrocel | Approved (phase 4) |
Clinical trials & evidence
Clinical trials
Clinical trials: 98.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| Not specified | 80 |
| PHASE3 | 6 |
| PHASE1 | 4 |
| PHASE2 | 3 |
| PHASE1/PHASE2 | 2 |
| EARLY_PHASE1 | 2 |
| PHASE4 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06184438 | PHASE4 | COMPLETED | Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery |
| NCT00450671 | PHASE3 | COMPLETED | Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug |
| NCT00475410 | PHASE3 | COMPLETED | Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease |
| NCT00929630 | PHASE3 | TERMINATED | Seton or Glue for Trans-sphincteric Anal Fistulas |
| NCT01478139 | PHASE3 | UNKNOWN | Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair |
| NCT01803347 | PHASE3 | COMPLETED | Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells |
| NCT05263661 | PHASE3 | UNKNOWN | Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula |
| NCT06303752 | PHASE1/PHASE2 | RECRUITING | Tissue Therapy of Transsphincteric Anal Fistula |
| NCT06632418 | PHASE2 | ACTIVE_NOT_RECRUITING | Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing |
| NCT00115466 | PHASE2 | UNKNOWN | Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula |
| NCT01372969 | PHASE1/PHASE2 | COMPLETED | Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn’s Disease. |
| NCT02456324 | PHASE2 | UNKNOWN | A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas |
| NCT04190862 | PHASE1 | RECRUITING | E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas |
| NCT06429241 | PHASE1 | RECRUITING | Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula |
| NCT04073472 | PHASE1 | WITHDRAWN | Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn’s |
| NCT05638139 | PHASE1 | COMPLETED | Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton’s Jelly |
| NCT07128953 | EARLY_PHASE1 | ENROLLING_BY_INVITATION | Study on the Mechanism of Zuoqing San Promoting Postoperative Wound Healing of Anal Fistula by Inhibiting ROS-dependent NETosis |
| NCT02423330 | EARLY_PHASE1 | TERMINATED | A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula |
| NCT01793168 | Not specified | RECRUITING | Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford |
| NCT02306382 | Not specified | RECRUITING | Multicenter Study for Diagnosis and Treatment of Perianal Abscesses |
| NCT03865823 | Not specified | ACTIVE_NOT_RECRUITING | Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre |
| NCT05243966 | Not specified | RECRUITING | Myriad™ Augmented Soft Tissue Reconstruction Registry |
| NCT05641844 | Not specified | RECRUITING | A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas |
| NCT05974280 | Not specified | RECRUITING | Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells |
| NCT06092398 | Not specified | NOT_YET_RECRUITING | Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula |
| NCT06548724 | Not specified | RECRUITING | Patient’s Quality of Life and Functional Changes After Fistula Surgery |
| NCT06798155 | Not specified | RECRUITING | Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery |
| NCT06803550 | Not specified | RECRUITING | Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions |
| NCT06962228 | Not specified | NOT_YET_RECRUITING | Cross-cultural Adaptation of the Chinese Version of QoLAF-Q (Quality of Life in Patients With Anal Fistula Questionnaire) ：A Multi-center Study |
| NCT07019532 | Not specified | NOT_YET_RECRUITING | Machine Learning-Based Risk Stratification for Fistula Formation After Perianal Abscess Drainage |
| NCT07081373 | Not specified | RECRUITING | Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients. |
| NCT07323160 | Not specified | NOT_YET_RECRUITING | Determining the Effect of Education Given to Patients Undergoing Outpatient Anal Fistula Surgery |
| NCT07477496 | Not specified | RECRUITING | Recurrence and Anal Fistula Patient Reported Outcomes Trial |
| NCT07482241 | Not specified | NOT_YET_RECRUITING | Impact of Surgical Timing on Anal Fistula Outcomes |
| NCT07579715 | Not specified | RECRUITING | Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In Perianal Fistula |
| NCT00545441 | Not specified | COMPLETED | A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas |
| NCT00610207 | Not specified | TERMINATED | Treatment of Crohn’s Fistula Using a Porcine Intestine Submucosa Graft |
| NCT00703131 | Not specified | COMPLETED | Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia |
| NCT00830661 | Not specified | UNKNOWN | Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair |
| NCT00951002 | Not specified | UNKNOWN | The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| DARVADSTROCEL | 4 | 2 |
| PHENYTOIN | 4 | 2 |
| CLINDAMYCIN | 4 | 1 |
| FIBRIN | 3 | 2 |
Related Atlas pages
- Drugs: Darvadstrocel, Phenytoin, Clindamycin, Fibrin