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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.
Full 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, 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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Inclusion criteria
All patients:
Crohn's disease (CD) patients only:
Exclusion criteria
All patients:
Crohn's disease patients only:
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Interventional model
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40 participants in 2 patient groups
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Central trial contact
Andreas Rickenbacher, MD; Benjamin Misselwitz, MD
Data sourced from clinicaltrials.gov
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