Photodynamic Therapy in Anal Fistula
- Conditions
- Rectal Fistula
- Interventions
- Procedure: photodynamic therapy
- Registration Number
- NCT03864718
- Lead Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- complex anal fistula according to Parks classification
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description complex anal fistula photodynamic therapy -
- Primary Outcome Measures
Name Time Method Healing 12 months after surgery Yes/Not
- Secondary Outcome Measures
Name Time Method