Efficacy of Photodynamic Therapy and Intra-lesional 5-wing in Complex Perianal Fistula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 49
- Primary Endpoint
- Healing
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •patients <18
- •immunocompromised
- •patients who refused consent.
Outcomes
Primary Outcomes
Healing
Time Frame: 12 months after surgery
Yes/Not
Secondary Outcomes
No secondary outcomes reported
Investigators
Antonio Arroyo Sebastian
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana