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
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 surgeon (for the diagnosing the perianal disease and assessing the need
for surgery) and a HBOT specialist for assessing the capability of the subject to undergo
HBOT treatment.After the screening period, eligible subjects will enter an 8 weeks HBOT
treatment period, combined with TNFalpha blocker treatment. This period will be followed by a
4 months follow-up period in which treatment with TNFalpha blocker will continue.
All patients will have an MRI and TRUS examinations to assess the fistulas and also blood
tests for CBC, chemistry, inflammatory markers and cytokine analysis. Same evaluation will be
repeated at the end of the study.
Condition:
Crohn’s Disease
Treatment:
Hyperbaric oxygen
Start Date:
March 2013
Sponsor:
Assaf-Harofeh Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT01828190