Hyperbaric Oxygen Therapy for the Treatment of Perianal fistulas In Crohn*s disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47818

Enrollment

Registered

2017-08-31

Start date

2017-10-09

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistulas in Crohn's disease sinus.

Interventions

40 sessions of HBO therapy at 2.4 atmosphere absolute.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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)

Design outcomes

Primary

Measure	Time frame
Changes in the perianal disease activity index (PDAI) and MRI-scores (co-primary endpoints). Assessment will be done at baseline, 16 weeks, 34 months (PDAI only) and 60 months after finishing HBO therapy.	—

Secondary

Measure	Time frame
Fistula drainage assessment (FDA), laboratory findings and patient-reported outcomes. Assessment will be done at baseline, 16 weeks, 34 months and 60 months after finishing HBO therapy.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)