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Fistulodesis Pilot Study for Closure of Perianal Fistulae

Primary Purpose

Perianal Fistula, Crohn Disease

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Fistulodesis

About this trial

This is an interventional treatment trial for Perianal Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
- 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)

Exclusion Criteria:

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.
- 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)

Sites / Locations

Division of Gastroenterology, University Hospital ZurichRecruiting
Bethanien-KlinikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with Crohn's Disease

Patients without IBD

Arm Description

20 patients with Crohn's Disease. Intervention: Fistulodesis

20 patients without underlying Inflammatory Bowel Disease. Intervention: Fistulodesis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement of quality of life

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

Improvement of PDAI

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

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

Risk factors for treatment failure

Risk factors for treatment failure (multivariate analysis)

Comparison of fistula closure rates in patients with CD and patients without IBD

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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).

Full Information

NCT ID

NCT03322488

First Posted

July 10, 2017

Last Updated

October 25, 2017

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT03322488

Brief Title

Fistulodesis Pilot Study for Closure of Perianal Fistulae

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perianal Fistula, Crohn Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

20 patients with Crohn's disease and 20 patients without Crohn's disease will be recruited

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with Crohn's Disease

Arm Type

Experimental

Arm Description

20 patients with Crohn's Disease. Intervention: Fistulodesis

Arm Title

Patients without IBD

Arm Type

Experimental

Arm Description

20 patients without underlying Inflammatory Bowel Disease. Intervention: Fistulodesis

Intervention Type

Procedure

Intervention Name(s)

Fistulodesis

Other Intervention Name(s)

Acetylcystein, Doxycycline, Evicel®, Metronidazole, Ciprofloxacin

Intervention Description

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).

Primary Outcome Measure Information:

Title

Fistulodesis success criteria

Description

Time Frame

week 24

Secondary Outcome Measure Information:

Title

Improvement of quality of life

Description

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

Time Frame

at week 24

Title

Improvement of PDAI

Description

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

Time Frame

at week 4, 12, 24

Title

Reduction in fistula activity

Description

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

Title

Risk factors for treatment failure

Description

Risk factors for treatment failure (multivariate analysis)

Time Frame

at week 24

Title

Comparison of fistula closure rates in patients with CD and patients without IBD

Description

Comparison of fistula closure rates in patients with CD and patients without IBD

Time Frame

at week 24

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

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

Title

Long-term follow-up

Description

Time Frame

at 12 months and 24 months

Other Pre-specified Outcome Measures:

Title

Microbiota composition of fistula tract

Description

We will analyze the curettage material from the fistula tract by 16S sequencing to determine microbiota composition. We will compare bacterial diversity (number bacterial species) from CD patients and patients without Crohn's disease

Time Frame

material obtained at baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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) Exclusion Criteria: 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. 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benjamin Misselwitz, MD

Phone

0041 044 255 1111

benjamin.misselwitz@usz.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Andreas Rickenbacher, MD

Phone

0041 44 255 1111

andreas.rickenbacher@usz.ch

Facility Information:

Facility Name

Division of Gastroenterology, University Hospital Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerhard Rogler, MD PhD

Phone

++41 44 255 9519

gerhard.rogler@usz.ch

First Name & Middle Initial & Last Name & Degree

Benjamin Misselwitz, MD

Phone

++41 44 255 1111

benjamin.misselwitz@usz.ch

First Name & Middle Initial & Last Name & Degree

Benjamin Misselwitz, MD

Facility Name

Bethanien-Klinik

City

Zürich

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniela Zeller, MD

Phone

+41 43 244 93 90

daniela.zeller@bethanien.ch

12. IPD Sharing Statement

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Fistulodesis Pilot Study for Closure of Perianal Fistulae

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