Hyperbaric Oxygen Therapy for the Treatment of Perianal fistulas In Crohn*s disease
- Conditions
- Fistulas in Crohn's diseasesinus.10017969
- Registration Number
- NL-OMON47818
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Confirmed diagnosis Crohn*s disease as specified in the guidelines of the European Crohn's and Colitis Organization
- Actively draining high perianal fistula (>1/3 through external sphincter), regardless of number
- Failure of treatment with standard care (medical and/or surgical) defined as persisting fistula drainage > 6 months or intolerance to standard treatment
- Standard care treatment regimen has been stable for at least six weeks (i.e. no starting of antibiotics, surgical intervention except seton placement, addition of immunosuppresants or dosage changes of biologicals)
- > 18 years
- Written informed consent
- Unfit for hyperbaric oxygen therapy as assessed by the hyperbaric physician
- Language barrier
- Unable to give informed consent
- Patients without a seton
- Patients with a seton in situ > 12 months
- Patients with anal stricture
- Patients with rectovaginal fistulas
- Patients with stoma
- Patients with proctitis on MRI, unless there is no deep ulceration in the rectum
- Presence of fluid collection/abscess that needs to be surgically drained
- Prior surgical procedure in the preceding 3 months (except for seton placement)
- Patients with a contraindication to undergo MRI (claustrophobia, intravenous contrast allergy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Changes in the perianal disease activity index (PDAI) and MRI-scores<br /><br>(co-primary endpoints). Assessment will be done at baseline, 16 weeks, 34<br /><br>months (PDAI only) and 60 months after finishing HBO therapy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Fistula drainage assessment (FDA), laboratory findings and patient-reported<br /><br>outcomes. Assessment will be done at baseline, 16 weeks, 34 months and 60<br /><br>months after finishing HBO therapy. </p><br>