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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
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.
Details
| Lead sponsor | University of Zurich |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 40 |
| Start date | 2017-06-20 |
| Completion | 2020-12 |
Conditions
- Perianal Fistula
- Crohn Disease
Interventions
- Fistulodesis
Primary outcomes
- Fistulodesis success criteria — week 24
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
Countries
Switzerland