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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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03864718
Study type Observational
Source Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact
Status Completed
Phase
Start date January 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
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Completed NCT04844593 - A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Recruiting NCT01615302 - Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter? N/A
Recruiting NCT05390151 - Laser Assisted Treatment of Fistula In Ano N/A
Completed NCT02402543 - Pre-Emptive Analgesia in Ano-Rectal Surgery N/A
Completed NCT04876690 - A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas
Active, not recruiting NCT00517296 - Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas N/A
Withdrawn NCT05407766 - Mesenchymal Stem Cells (MSCs) for Perianal Fistula Phase 1