Hyperbaric Oxygen Therapy for the Treatment of Perianal fistulas In Crohn’s disease
Completed
- Conditions
- Crohn's disease, Morbus Crohn, perianal fistula(s), fistulising Crohn's disease, inflammatory bowel disease, IBD.Ziekte van Crohn, perianale fistels, fistelende ziekte van Crohn, inflammatoire darmziekte.
- Registration Number
- NL-OMON23412
- Lead Sponsor
- Academic Medical Centre, Amsterdam
- Brief Summary
.A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Confirmed diagnosis Crohn’s disease
-Actively draining high perianal fistula (>1/3 through external sphincter), regardless of number
Exclusion Criteria
-Unfit for hyperbaric oxygen therapy as assessed by the hyperbaric physician
-Language barrier
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Co-primary parameters: <br /><br>-Perianal disease activity index (PDAI) as assessed by the primary physician (gastroenterologist or surgeon) and patient. <br /><br>-MRI-imaging, assessed by an independent radiologist using the (modified) van Assche score.
- Secondary Outcome Measures
Name Time Method -Fistula drainage assessment (FDA) performed by the primary physician. <br /><br>-Laboratory findings (CRP and fecal calprotectin). <br /><br>-Patient reported outcomes (PROs: IBDQ and EQ-5D-5L). <br /><br>-(Changes in) use of concomitant medication, among which the number of courses of antibiotics, within the course of the study (60 weeks). <br /><br>-Re-interventions within the course of the study (60 weeks). <br /><br>-Complications during HBO.