Fistula in Ano

9

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

Condition / disease
Location
Status: Not yet recruiting

Seton Re-routing for High Perianal Fistula

High perianal fistulae involve a significant portion of the external anal sphincter muscle, making standard surgical fistulotomy risky due to the potential for postoperative fecal incontinence. Sphincter-preserving techniques aim to eradicate the fistula tract and promote healing while safeguarding anal continence. The purpose of this prospective, single-arm clinical study is to evaluate the efficacy and safety of the two-stage seton re-routing technique in adult patients diagnosed with high perianal fistula at Assiut University Hospital. The procedure is conducted in two stages: * First Stage: Identification and curettage of the fistula tract followed by placement of a loose draining seton to clear local sepsis and allow fibrous maturation over an interval of 6 to 12 weeks. * Second Stage: Creation of a low submucosal or intersphincteric tunnel beneath the main external anal sphincter complex. The seton is unthreaded and re-routed through this lower pathway, isolating the upper transsphincteric tract so it can heal spontaneously by secondary fibrosis. The resulting downstaged superficial tract is then laid open (low fistulotomy) or managed with staged seton tightening. Participants will be monitored weekly during the first month, followed by regular monthly follow-up visits for a minimum of 6 to 9 months postoperatively. The study assesses complete fistula healing, recurrence rates, healing time, operative duration, postoperative complications, and anal continence status evaluated using the Cleveland Clinic (Wexner) Incontinence Score preoperatively and at 3, 6, and 9 months after surgery.

Participants needed: 35
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Sep 30, 2026
Eligibility criteria

Age 18 years or older, of either sex. [+3]

Fistula secondary to inflammatory bowel disease (Crohn's disease or ulcerative c... [+2]

Status: Not yet recruiting

Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC

Background: Fistula tract laser closure (FiLaC) has emerged as a sphincter-preserving treatment for anal fistula (AF). However, the optimal role of preoperative bowel preparation (BP) in enhancing postoperative outcomes remains contentious. While some surgeons recommend enemas to empty the rectum, others ignore BP altogether due to concerns about possible contamination from enemas. Current guidelines suggest that the decision to perform BP is at the surgeon's discretion, as it is not definitively linked to healing rates. Objective: This prospective, non-randomized observational cohort study aims to evaluate whether preoperative bowel preparation significantly impacts primary healing rates following FiLaC in patients with anal fistula. Methods: One hundred consecutive patients undergoing FiLaC will be prospectively enrolled and stratified into two cohorts: Group A (BP) and Group B (no BP). Anal fistulas will be classified by Parks classification. The primary outcome is complete clinical healing at three months, defined by the absence of discharge, an epithelialized external opening, and no recurrence. Secondary outcomes include six-month healing rates, recurrence, postoperative pain, quality of life, Wexner continence scores, and complication rates. Multivariate logistic regression will be employed to control for potential confounders, including smoking status, prior seton use, and fistula complexity. Discussion: This study aims to fill the evidence gap regarding the benefits of preoperative BP in FiLaC procedures, improving perioperative protocols to optimize healing outcomes while reducing unnecessary interventions. The findings will provide clinicians with evidence-based guidance on BP strategies.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Acibadem Kent HospitalUpdated: Sep 2, 2026Duration: 6 Months
Eligibility criteria

Age ≥18 years [+3]

Fistula associated with Crohn's disease, tuberculosis, or malignancy [+4]

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: Recruiting

BioHealx® Anal Fistula Device Post Market Surveillance Study

This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).

Participants needed: 50
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: Signum Surgical USA Inc.Updated: Jun 3, 2026Locations: 6Duration: 36 Months
Eligibility criteria

Age 18 - 75 years [+4]

Fistula tract shorter than 2cm [+18]

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: Recruiting

Fistula-in-ano in Infants and Children

In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.

Participants needed: 20
Trial details
Age: Up to 18Biological sex: AllType: InterventionalSponsor: Friedrich-Alexander-Universität Erlangen-NürnbergUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

any patient with FIA and treatment with non-cutting seton placement in our insti... [+2]

none

Status: Recruiting

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease

Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).

Participants needed: 5
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: CryoCord Sdn BhdUpdated: May 11, 2025Locations: 1
Eligibility criteria

Adult men and women age 18 years and above. [+3]

Informed consent refusal. [+8]

Status: Recruiting

Collagen Paste vs Mucosal Advancement Flap for FIA

The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.

Participants needed: 118
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Chinese University of Hong KongUpdated: Apr 26, 2024Locations: 2
Eligibility criteria

Clinical diagnosis of high cryptoglandular fistula-in-ano. [+6]

Unable/unwilling to provide informed consent. [+9]