Crohn Disease Clinical Trial
Official title:
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.
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, doxycycline and fibrin glue in the fistula tract.
Fistulodesis comprises the following steps:
- Curettage of fistula tract
- Mini-excision of the inner (endoanal) fistula opening
- Flushing of fistula tract with acetylcysteine
- Flushing/ filling of the fistula tract with doxycycline
- Filling the fistula tract with fibrin glue
- Surgical closure of inner (rectal) and outer (skin) fistula openings with a Z-suture
- Antibiotic treatment with metronidazole/ ciprofloxacin for 10 days after surgery
Agglutination of the fistula tract is a central part of this study. Agglutinative properties
of doxycycline are frequently used by pneumologists for pleurodesis (artificial adhesion of
the pleurae to occlude the pleural space for the treatment of pneumothorax or other
conditions). Doxycycline (or tetracycline) is thereby instilled into the pleural space,
leading to local inflammation and finally pleurodesis. Pleurodesis is an efficient procedure
with closure rates >80%. The investigators are expecting to achieve high closure rates also
for fistulae.
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