Hyperbaric Oxygen Therapy for the treatment of RectoVaginal fistulas in Crohn's Disease.
Recruiting
- Conditions
- Crohn's disease, rectovaginal fistulas, inflammatory bowel disease.
- Registration Number
- NL-OMON24386
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Confirmed diagnosis Crohn’s disease as specified in the guidelines by the European Crohn’s and Colitis Organisation 17
-One or more rectovaginal fistula(s), defined as:
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 Clinical closure of fistula, defined as cessation of complaints, i.e. passage of feces or flatus per vagina, or closure of the external orifice if visible at baseline.
- Secondary Outcome Measures
Name Time Method -Response/remission of co-existing perianal fistulas measured by PDAI (perianal disease activity index) and FDA (fistula drainage assessment)<br /><br>-Patient reported outcomes (PROs: EQ-5D-5L, IBDQ, FIQL, FSFI, decision regret scale) <br /><br>-(Changes in) use of concomitant medication within the course of the study (58 weeks)<br /><br>-Re-interventions for both luminal as well as perianal disease within the course of the study (58 weeks)<br /><br>-Percentages of and reasons for refusal to participate (in) or finish the study, if available<br /><br>-Adverse events during HBO and during follow-up