Status:
COMPLETED
The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Crohn's Disease
Perianal Fistulas
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patient suffering from residual Crohn's disease related perianal fistulas already treated with TNF alpha blockers
Detailed Description
This study is a prospective open-label study that consists three periods: screening, treatment and follow-up. After signing an informed consent, subjects will be assessed by a gastroenterologist, a su...
Eligibility Criteria
Inclusion
- patients aged 18 and above that suffer from Crohn's disease one or more perianal draining fistulas for at least 3 months currently receiving a TNFalpha blocker for at least 3 months (without improvement of the perianal disease)
Exclusion
- Pregnancy or plans to conceive during the next year Inability (such as previous adverse effects, tuberculosis, concurrent infection etc.)or unwillingness to start or continue with TNF alpha blockers treatment.
- Any past or current malignancy Treatment with HBOT in the last year Claustrophobia Middle ear problems Inability to equalize pressure in the middle ear Medical status that precludes treatment with HBOT such as chest X-ray abnormality, epilepsy, severe congestive heart failure, uncontrolled diabetes or uncontrolled hypertension Any perianal surgery in the last 6 months Any change in Crohn's disease medications in the last 3 months
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01828190
Start Date
March 1 2013
End Date
July 1 2015
Last Update
March 22 2023
Active Locations (1)
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1
The institute of gastroenterology and liver disease, Assaf Harofe Medical Center
Ẕerifin, Israel, 70800