Photodynamic Therapy in Anal Fistula

Rectal Fistula Clinical Trial

Official title:

Efficacy of Photodynamic Therapy and Intra-lesional 5-wing in Complex Perianal Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864718
• Other study ID #: TFD-ALA
• Status: Completed
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Rectal Fistula

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing	Yes/Not	12 months after surgery