This study aims to test a new treatment called hyperbaric oxygen therapy (HBOT) for a severe type of inflammatory bowel disease called perianal Crohn's disease (PCD). PCD causes painful perianal infections and chronic drainage from fistula tracts, and current treatments are only moderately effective and may not be suitable for all patients. HBOT is a safe and commonly used treatment for chronic non-healing wounds and other conditions. Previous studies have suggested that HBOT may help heal fistulas in PCD patients, but these studies were small and lacked controls.
Adults (>19 years old)
Diagnosis of Crohn's disease based on standard endoscopic, radiologic and/or histologic criteria.
One or more perianal fistula tract connecting the rectum and the perianal skin. Patients must have active fistula drainage and/or a recurrent perianal abscess within the past month.
Failure or intolerance of conventional therapy (imuran, methotrexate, anti-TNF therapies, vedolizumab and/or ustekinumab). Failure is defined as persistent perianal drainage or recurrent abscesses after a minimum of 3 months of therapy.
Fistulas not believed to be due to Crohn's disease (examples include, obstetrical complications, tuberculosis, anorectal cancer or diverticular fistula).
Rectovaginal fistulas.
Undrained perianal abscesses on pelvic MRI exams (abscesses will require successful drainage by an exam under anaesthesia with or without seton prior to study inclusion).
Surgical procedure such as an advancement flap, fistula plug, fistula glue or ligation of intersphincteric fistula tract (LIFT) procedure within the past 6 months.
Parallel
Oxygen Gas for Inhalation
DrugThe active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM).
Standard of care
Other interventionThe accepted standard of care for perianal Crohn's disease (PCD) involves conventional therapies such as immunosuppressive agents and biologics, which can be used to induce and maintain fistula remission.
Phase 1 recruitment rate
Primary outcome for phase 1 is the rate of recruitment. Recruitment is defined as the number of randomized patients that receive at least one treatment (active HBOT or control) per year. After one year, recruitment of 20 patients or more (an average of 4 patients per site) will be considered acceptable to proceed to phase 2 without a requirement for modifications, recruitment of 10-20 patients will suggest minor modifications to the protocol are required and recruitment of less than 10 patients will suggest major modifications to the protocol are required prior to proceeding to phase 2.
Phase 2 numbers of closure all external openings of fistula tracts
The primary outcome for phase 2 is the proportion of patients who achieve combined remission of perianal fistulizing Crohn's Disease at week 12 defined as closure of all external openings by finger compression test, and an absence of collections \>2 cm confirmed by MRI assessment assessed at 8-12 weeks. MRI pelvis is the optimal outcome measure for measuring response to treatment as it has been shown to be the most accurate test for predicting long-term outcomes.
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University of British Columbia
Lead sponsor
The Ottawa Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
