NCT03322488

Fistulodesis Pilot Study for Closure of Perianal Fistulae

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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, 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.

Conditions

• Perianal Fistula
• Crohn Disease

Interventions

Type	Name	Description
PROCEDURE	Fistulodesis	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).

Timeline

• Start date: 2017-06-20
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-10-26
• Last updated: 2017-10-26

Locations

2 sites across 1 country: Switzerland