NCT03864718

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

March 3, 2019

Last Update Submit

March 5, 2019

Conditions

Rectal Fistula

Outcome Measures

Primary Outcomes (1)

  • Healing

    Yes/Not

    12 months after surgery

Study Arms (1)

complex anal fistula

Procedure: photodynamic therapy

Interventions

photodynamic therapyPROCEDURE

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).

complex anal fistula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • complex anal fistula according to Parks classification

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Fistula

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2019

First Posted

March 6, 2019

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03