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Perianal FistulaNCT03322488

Fistulodesis Pilot Study for Closure of Perianal Fistulae

A study testing Fistulodesis in people with Perianal Fistula and Crohn Disease, run by University of Zurich at 2 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Perianal Fistula, Crohn Disease
What is being tested?
Fistulodesis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesSwitzerland
Study dates
20 Jun 2017to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients:
  • Signed informed consent
  • Male or female patients ≥18 years of age
  • Perianal fistula existing for at least 3 months
  • Perianal fistula that requires an examination under anaesthesia (EUA)
  • Women of childbearing potential must agree to use effective contraception (for details see chapter 8.6) for the duration of the trial
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  • Women of childbearing potential: A negative pregnancy test before inclusion into the trial is required
  • Simple fistula, the whole fistula system must be accessible by curettage or brushing
  • Crohn's disease (CD) patients only:
  • CD diagnosis established for ≥3 months
  • CD in remission (Harvey-Bradshaw Index ≤4)

Who cannot join

  • All patients:
  • More than 2 external fistula openings
  • History of irradiation of the anorectum
  • Acute perianal abscess.
  • Perianal operation during the last 4 weeks.
  • Known allergy or non-tolerance against either acetylcysteine, doxycycline, Evicel®, metronidazole or ciprofloxacin.
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  • Current antibiotic therapy
  • Severe uncontrolled additional medical, surgical or psychiatric condition, requiring active management
  • Current enrollment into a clinical trial interfering with the endpoints or enrollment in another study for treatment of perianal fistula during the last 4 weeks
  • Inability to follow the procedures of the study, e.g. due to language problems, psychiatrical disorders, dementia, etc. of the participant,
  • Previous enrollment into the current study
  • Women who are pregnant or breastfeeding
  • Intention to become pregnant during the course of the study
  • Large pocket (≥ 1cm) within fistula tract
  • Horseshoe shape of the fistula tract
  • Superficial fistula according to clinical examination and/or ultrasound: (Male patients: Fistula tract involves less than 30% of anal sphincter apparatus, Female patients: Fistula tract involves less than 10% of anal sphincter apparatus)
  • Crohn's disease patients only:
  • Evidence of active inflammation in the rectum (besides the fistula)
  • Systemic intake of steroid-medication (currently or during the last 4 weeks) in a dose of >20mg prednisone or equivalent
  • New immunosuppressant medication for Crohn's disease within the last 4 weeks before inclusion into the study (changes in 5-ASA medication or rectal treatment with 5-ASA or budesonide are permitted)

Trial locations and contacts

2 sites in 1 country.

Benjamin Misselwitz, MD contact

0041 044 255 1111

benjamin.misselwitz@usz.ch

Andreas Rickenbacher, MD contact

0041 44 255 1111

andreas.rickenbacher@usz.ch

Switzerland2 sites, 2 recruiting

  • Division of Gastroenterology, University Hospital Zurich

    Zurich, 8091

    Gerhard Rogler, MD PhD, ++41 44 255 9519, gerhard.rogler@usz.ch

    Benjamin Misselwitz, MD, ++41 44 255 1111, benjamin.misselwitz@usz.ch

    Recruiting

  • Bethanien-Klinik

    Zurich

    Daniela Zeller, MD, +41 43 244 93 90, daniela.zeller@bethanien.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
Fistulodesis
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FistulodesisProcedure or surgery

    Also called Acetylcystein, Doxycycline, Evicel®, Metronidazole

    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).

Study groups in NCT03322488
Study groupRoleWhat they receive
Patients with Crohn's DiseaseExperimental20 patients with Crohn's Disease. Intervention: Fistulodesis
Receives: Procedure: Fistulodesis
Patients without IBDExperimental20 patients without underlying Inflammatory Bowel Disease. Intervention: Fistulodesis
Receives: Procedure: Fistulodesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fistulodesis 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

    Measured: week 24

Secondary outcomes (7)

  1. Improvement of quality of life

    Improvement of quality of life (IBD-Q) at week 24 compared to baseline

    Measured: at week 24

  2. Improvement of PDAI

    Improvement of PDAI (Peranal Disease Activity Index) at week 4, 12, 24 compared to baseline

    Measured: at week 4, 12, 24

  3. 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

    Measured: at week 4, 12 and 24

  4. Risk factors for treatment failure

    Risk factors for treatment failure (multivariate analysis)

    Measured: at week 24

  5. 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

    Measured: at week 24

  6. 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

    Measured: at weeks 4, 12, 24, 12 months and 24 months

  7. 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).

    Measured: at 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start20 Jun 2017
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
20 patients with Crohn's disease and 20 patients without Crohn's disease will be recruited
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322488
Sponsor's protocol ID
BASEC 2016-01310
Status last verified
Oct 2017
First submitted
10 Jul 2017
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Fistulodesis in people with Perianal Fistula and Crohn Disease, run by University of Zurich at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benjamin Misselwitz, MD (0041 044 255 1111, benjamin.misselwitz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fistulodesis success criteria (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03322488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.

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