Rectal Fistula
Conditions
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).
Interventions
PROCEDUREphotodynamic therapy
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).
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * ASA IV * patients \<18 * immunocompromised * patients who refused consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing | 12 months after surgery | Yes/Not |
Outcome results
None listed