Photodynamic Therapy in Anal Fistula

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana49 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rectal Fistula

Interventions

photodynamic therapyPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Photodynamic Therapy in Anal Fistula

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes