Status:
UNKNOWN
Fistulodesis Pilot Study for Closure of Perianal Fistulae
Lead Sponsor:
University of Zurich
Conditions:
Perianal Fistula
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 proc...
Detailed Description
The investigators want to test Fistulodesis as a new treatment option which combines established low-invasive surgical and medical treatment steps with the local application of acetylcysteine, doxycyc...
Eligibility Criteria
Inclusion
- 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
- Women of childbearing potential: A negative pregnancy test before inclusion into the trial is required
- 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)
Exclusion
- 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
- Superficial fistula according to clinical examination and/or ultrasound: (Male patients: Fistula tract involves less than 30% of anal sphincter apparatus, Female patients: Fistula tract involves less than 10% of anal sphincter apparatus)
- Crohn's disease patients only:
- Evidence of active inflammation in the rectum (besides the fistula)
- Systemic intake of steroid-medication (currently or during the last 4 weeks) in a dose of \>20mg prednisone or equivalent
- New immunosuppressant medication for Crohn's disease within the last 4 weeks before inclusion into the study (changes in 5-ASA medication or rectal treatment with 5-ASA or budesonide are permitted)
Key Trial Info
Start Date :
June 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03322488
Start Date
June 20 2017
End Date
December 1 2020
Last Update
October 26 2017
Active Locations (2)
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1
Division of Gastroenterology, University Hospital Zurich
Zurich, Switzerland, 8091
2
Bethanien-Klinik
Zurich, Switzerland