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Fistulodesis Pilot Study for Closure of Perianal Fistulae

NCT03322488 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-26

No results posted yet for this study

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.

Conditions

  • Perianal Fistula
  • Crohn Disease

Interventions

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).

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03322488 on ClinicalTrials.gov