Photodynamic Therapy in Anal Fistula

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Completed

Conditions: Rectal Fistula

Treatments: Procedure: photodynamic therapy

Study type: Observational

Funder types: Other

Identifiers

NCT03864718

TFD-ALA

Details and patient eligibility

About

Objective: Validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula.

Methods: Prospective observational study including patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). Patients were included with a minimum follow up of 1-year, in order to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• complex anal fistula according to Parks classification

Exclusion criteria

• Non cryptoglandular fistulas
• acute sepsis
• inflammatory bowel diseases
• simple fistulas (defined as subcutaneous, intersphincteric and low transsphincteric fistula)
• pregnant patients
• ASA IV
• patients <18
• immunocompromised
• patients who refused consent.

Trial design

49 participants in 1 patient group

complex anal fistula

Treatment:

Procedure: photodynamic therapy