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

Academisch Medisch Centrum0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•- 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)

发起方