Hyperbaric Oxygen Therapy for the Treatment of Perianal fistulas In Crohn*s disease - HOT-TOPIC trial

Academisch Medisch Centrum0 sites30 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 21, 2020

Last Updated

last year

Study Type

Interventional

Sponsor

•\- 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