Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
49 participants
OBSERVATIONAL
2016-01-31
2018-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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complex anal fistula
photodynamic 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).
Interventions
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photodynamic 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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
OTHER
Responsible Party
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Antonio Arroyo Sebastian
Principal Investigator
Other Identifiers
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TFD-ALA
Identifier Type: -
Identifier Source: org_study_id
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