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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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).
Division of Gastroenterology, University Hospital Zurich
Zurich, Switzerland
RECRUITINGBethanien-Klinik
Zurich, Switzerland
RECRUITINGFistulodesis 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
Time frame: week 24
Improvement of quality of life
Improvement of quality of life (IBD-Q) at week 24 compared to baseline
Time frame: at week 24
Improvement of PDAI
Improvement of PDAI (Peranal Disease Activity Index) at week 4, 12, 24 compared to baseline
Time frame: at week 4, 12, 24
Reduction in fistula activity
Reduction in fistula activity assessed by fistula drainage assessment (FDA) and "Fistulodesis success criteria" at week 4, 12 and 24 compared to baseline
Time frame: at week 4, 12 and 24
Risk factors for treatment failure
Risk factors for treatment failure (multivariate analysis)
Time frame: at week 24
Comparison of fistula closure rates in patients with CD and patients without IBD
Comparison of fistula closure rates in patients with CD and patients without IBD
Time frame: at week 24
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Time frame: at weeks 4, 12, 24, 12 months and 24 months
Long-term follow-up
Long-term follow-up (12 months, 24 months after the end of the study): Assessment of the long-term success after 12 and 24 months by telephone. The patients will be asked about possible fistula symptoms (pain, drainage).
Time frame: at 12 months and 24 months