Fistulodesis Pilot Study for Closure of Perianal Fistulae
Local Installation of Acetylcysteine, Doxycycline and Fibrin Glue and Surgical Closure of Fistula Openings for Treatment of Perianal Fistulae. An Open Label, Prospective, Multicentric Pilot Study
1 other identifier
interventional
40
1 country
2
Brief Summary
In this pilot study a new surgical treatment approach for perianal fistulae, called Fistulodesis, is performed. The study aims to assess effectiveness, safety and tolerability of the Fistulodesis procedure. The investigators are aiming to include 20 patients with Crohn's disease and 20 patients without underlying Crohn's disease. It is an open label study with an anticipated duration from January 2017 to January 2020.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2017
CompletedFirst Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 26, 2017
October 1, 2017
3.5 years
July 10, 2017
October 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Fistulodesis success criteria
Closure of all perianal fistula tracts of a patient at week 24 as defined by the presence of all of the following "Fistulodesis success criteria": * No secretion from fistula during the last 2 weeks as reported by the patient * No secretion upon careful pressing onto fistula tract * Fistula tract outer opening macroscopically closed upon inspection * No pain at the site of the former fistula opening during gentle pressing
week 24
Secondary Outcomes (7)
Improvement of quality of life
at week 24
Improvement of PDAI
at week 4, 12, 24
Reduction in fistula activity
at week 4, 12 and 24
Risk factors for treatment failure
at week 24
Comparison of fistula closure rates in patients with CD and patients without IBD
at week 24
- +2 more secondary outcomes
Other Outcomes (1)
Microbiota composition of fistula tract
material obtained at baseline
Study Arms (2)
Patients with Crohn's Disease
EXPERIMENTAL20 patients with Crohn's Disease. Intervention: Fistulodesis
Patients without IBD
EXPERIMENTAL20 patients without underlying Inflammatory Bowel Disease. Intervention: Fistulodesis
Interventions
Fistulodesis comprises the following treatment steps: * Curettage and/or brushing of the fistula tract * Mini-excision of the inner (endoanal) fistula opening * Flushing of fistula tract with acetylcysteine (Concentration: 100mg/ml, max. dosage: 20ml) * Flushing/ filling of fistula tract with doxycycline (Concentration: 20mg/ml, max. dosage: 10ml) * Filling the fistula tract with fibrin-glue (Evicel®). The maximum amount of Evicel® injected will be 20 ml of the combined product. * Surgical closure of inner (endoanal) fistula opening using a Z-suture (Vicryl 3.0) * Surgical closure of the outer fistula opening using a Z-suture (Vicryl 3.0) Metronidazole and ciprofloxacin will be used at 500mg two times per day for 10 days after the intervention (baseline).
Eligibility Criteria
You may qualify if:
- All patients:
- Signed informed consent
- Male or female patients ≥18 years of age
- Perianal fistula existing for at least 3 months
- Perianal fistula that requires an examination under anaesthesia (EUA)
- Women of childbearing potential must agree to use effective contraception (for details see chapter 8.6) for the duration of the trial
- Simple fistula, the whole fistula system must be accessible by curettage or brushing
- Crohn's disease (CD) patients only:
- CD diagnosis established for ≥3 months
- CD in remission (Harvey-Bradshaw Index ≤4)
You may not qualify if:
- All patients:
- More than 2 external fistula openings
- History of irradiation of the anorectum
- Acute perianal abscess.
- Perianal operation during the last 4 weeks.
- Known allergy or non-tolerance against either acetylcysteine, doxycycline, Evicel®, metronidazole or ciprofloxacin.
- Current antibiotic therapy
- Severe uncontrolled additional medical, surgical or psychiatric condition, requiring active management
- Current enrollment into a clinical trial interfering with the endpoints or enrollment in another study for treatment of perianal fistula during the last 4 weeks
- Inability to follow the procedures of the study, e.g. due to language problems, psychiatrical disorders, dementia, etc. of the participant,
- Previous enrollment into the current study
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the course of the study
- Large pocket (≥ 1cm) within fistula tract
- Horseshoe shape of the fistula tract
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Division of Gastroenterology, University Hospital Zurich
Zurich, 8091, Switzerland
Bethanien-Klinik
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2017
First Posted
October 26, 2017
Study Start
June 20, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
October 26, 2017
Record last verified: 2017-10