Perianal Fistula

9

Review clinical trials related to Perianal Fistula. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders. In Japan particularly, the incidence of anal lesions is high, with approximately half of patients developing fistulas or abscesses, significantly impairing quality of life (QOL). For perianal fistulizing Crohn's disease (PFCD), combined treatment with surgical intervention (e.g., seton placement) and medical therapy centered on anti-TNF agents is standard. However, challenges remain regarding efficacy rates and evaluation criteria. Novel therapies such as stem cell therapy, JAK inhibitors, and IL-23 inhibitors are gaining attention. This study using risankizumab aims to be the first in Japan to comprehensively evaluate the therapeutic efficacy of PFCD using both clinical and MRI assessments, thereby contributing to future treatment standardization and guideline development.

Participants needed: 25
Trial details
Phase: Phase 4Age: 15+Biological sex: AllType: InterventionalSponsor: Yuki HorioUpdated: Oct 13, 2026Locations: 4
Eligibility criteria

15 years of age or older [+5]

Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fi... [+20]

Status: Not yet recruiting

FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)

Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial

Participants needed: 25
Trial details
Age: Up to 18Biological sex: AllType: InterventionalSponsor: Complejo Hospitalario Universitario de SantiagoUpdated: Sep 9, 2026
Eligibility criteria

Cryptoglandular perianal fistula with at least 2 previous documented surgical fa... [+8]

Crohn's disease or ulcerative colitis [+8]

Status: Not yet recruiting

Open Fistulectomy vs. Laser Closure for Low Perianal Fistula

Perianal fistula is an abnormal tunnel connecting the anal canal to the perianal skin, frequently causing chronic pain, discharge, and impaired quality of life. Traditional open fistulectomy is an established treatment with high healing rates, but it leaves an open wound that requires prolonged recovery and carries a risk of anal sphincter injury. Fistula-tract Laser Closure (FiLaC) is a minimally invasive, sphincter-preserving technique that uses laser thermal energy to close the tract from within while minimizing tissue trauma. This study is a prospective, randomized controlled trial designed to compare the efficacy and safety of open fistulectomy versus laser fistulotomy in adult patients with primary low perianal fistula. Participants are randomly assigned to one of two surgical treatment groups: * Group 1: Laser fistulotomy (FiLaC) using a 1470 nm diode laser probe to seal the tract, combined with internal opening closure. * Group 2: Conventional open fistulectomy involving complete excision of the fistula tract, allowing the wound to heal by secondary intention. Patients are evaluated during surgery and followed postoperatively at 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months. The primary goals are to assess fistula healing rates and postoperative pain levels. Secondary goals include evaluating operative time, intraoperative blood loss, wound healing duration, complication rates, time to return to daily activities, fecal continence (measured by the Wexner Continence Score), and quality of life.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Sep 1, 2026
Eligibility criteria

Adult patients aged 18 years and above. [+4]

Complex or high perianal fistulae (suprasphincteric, extrasphincteric, or involv... [+9]

Status: Not yet recruiting

MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease

This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease. Fifty participants with complex draining fistulas will undergo staged surgical management followed by mirikizumab induction and maintenance therapy. The primary endpoint is combined clinical remission and radiologic response at Week 24. Participants will be followed through Week 48.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Icahn School of Medicine at Mount SinaiUpdated: Aug 24, 2026Locations: 2
Eligibility criteria

Adults ≥18 years [+3]

Rectovaginal fistula [+10]

Status: Not yet recruiting

Laser Ablation Versus Conventional Fistulectomy for Uncomplicated Perianal Fistula

This randomized controlled trial aims to compare conventional open fistulectomy and laser ablation in the treatment of uncomplicated perianal fistula. The study will evaluate postoperative recovery time and recurrence rates between the two procedures. A total of 72 patients with uncomplicated perianal fistula will be randomly assigned to either conventional open fistulectomy or laser ablation and followed for six months after surgery.

Participants needed: 72
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: PNS Hafeez - Naval HospitalUpdated: Jul 2, 2026Locations: 1
Eligibility criteria

Age 18 to 55 years. [+5]

Recurrent fistula. [+4]

Status: Recruiting

The Impact of Perianal Disease on Patient's Sex Life

Perianal diseases, such as perianal abcesses, anal fistulae and perianal Crohn's disease, are often associated with significant physical symptoms, including pain and chronic drainage. However, the impact of these conditions on a patient's personal life, intimacy, and body image-often referred to as "hidden morbidity"-is frequently overlooked in clinical practice. The purpose of this prospective observational study is to evaluate the psychosexual burden in patients suffering from chronic perianal disease. Using validated tools (IIEF-5 for men, FSFI-6 for women) and a specialized Supplemental Patient-Reported Outcome Measure (PROM), researchers will investigate how the presence of surgical devices (such as setons), disease etiology, and clinical symptoms affect sexual function and self-esteem. The study also aims to identify gaps in physician-patient communication regarding sexual health. By quantifying these impacts, the study seeks to promote a more holistic, patient-centered approach to the surgical management of perianal conditions.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: AHEPA University HospitalUpdated: Apr 9, 2026Locations: 1Duration: 3 Months
Eligibility criteria

Diagnosis of chronic perianal disease (fistula-in-ano, pCD, pilonidal). [+3]

Active malignancy (colorectal or anal cancer). [+2]

Status: Not yet recruiting

Role of MRI in Perianal Fistula

The aim of this study is to assess the diagnostic accuracy of MRI in detecting and assessment the primary fistulous tract, internal openings, secondary extensions, and associated abscesses. (and compare these findings with the surgical findings in patients who underwent surgery).

Participants needed: 30
Trial details
Biological sex: AllType: ObservationalSponsor: Sohag UniversityUpdated: Apr 3, 2026Locations: 1
Eligibility criteria

Patients clinically diagnosed or suspected to have perianal fistula. [+2]

Patients with contraindications to MRI, such as pacemakers, metallic implants, o... [+1]

Status: Recruiting

Recurrence and Anal Fistula Patient Reported Outcomes Trial

Perianal fistulas are a chronic anorectal condition associated with significant morbidity, including pain, persistent discharge, infection, and impaired continence, all of which can substantially affect patients' quality of life. Surgical management aims to eradicate the fistulous tract while preserving anal sphincter function and continence. Despite numerous available surgical techniques, high-quality comparative evidence regarding optimal management remains limited. This prospective observational study aims to evaluate clinical outcomes, functional outcomes, and patient-reported quality of life following surgical treatment of perianal fistulas. The study will collect both clinician-reported and patient-reported outcomes over a 12-month follow-up period. Outcomes of interest include fistula healing, recurrence, postoperative complications, continence status, symptom burden, and health-related quality of life. The findings are expected to provide real-world data that may inform clinical decision-making and contribute to improved patient-centered care.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: National and Kapodistrian University of AthensUpdated: Mar 19, 2026Locations: 1Duration: 24 Months
Eligibility criteria

Age ≥ 18 years. [+5]

Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis). [+6]

Status: Not yet recruiting

Comparing Three Surgical Techniques for the Treatment of Transsphincteric Perianal Fistula: (1) Traditional Fistulotomy (Lay Open), (2) Ligation of the Intersphincteric Tract (LIFT) With Adjunctive Endo Fistula Laser Ablation, and (3) Open LIFT Procedure Followed by LASER

\>This randomized clinical trial compares three different surgical techniques for the treatment of transsphincteric perianal fistula: (1) traditional fistulotomy (lay open), (2) ligation of the intersphincteric tract (LIFT) with adjunctive endofistula laser ablation, and (3) open LIFT procedure followed by direct laser ablation of the tract under vision. The aim is to determine which approach offers the highest healing rate, lowest recurrence, and best postoperative outcomes with minimal impact on continence.

Participants needed: 90
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Alexandria UniversityUpdated: Nov 21, 2025
Eligibility criteria

Adults aged 18-65 [+3]

Crohn's disease or other inflammatory bowel disease [+5]