The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
Prospective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha Blockers
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 22, 2023
April 1, 2013
2 years
April 8, 2013
March 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of fistulas number
As assessed by MRI and TRUS
0, 32 weeks
Secondary Outcomes (1)
Reduction of perianal symptoms
0, 4, 8, 14, 20, 32
Study Arms (1)
Hyperbaric oxygen
EXPERIMENTALhyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment.
Interventions
HBOT will be given for 40 sessions of 2 atmospheres for 90 minutes each session, 5 times a week (2 months). TNF alpha blocker therapy will remain the treatment received before recruitment.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The institute of gastroenterology and liver disease, Assaf Harofe Medical Center
Ẕerifin, 70800, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haim Shirin, MD
Assaf Harofe Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 10, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2015
Study Completion
July 1, 2015
Last Updated
March 22, 2023
Record last verified: 2013-04