Photodynamic Therapy in Anal Fistula

March 5, 2019 updated by: Antonio Arroyo Sebastian, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

49

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
complex anal fistula
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: 12 months after surgery
Yes/Not
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (ACTUAL)

March 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFD-ALA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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