The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
Recruitment status was Recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Reduction of fistulas number [ Time Frame: 0, 32 weeks ] [ Designated as safety issue: No ]As assessed by MRI and TRUS
- Reduction of perianal symptoms [ Time Frame: 0, 4, 8, 14, 20, 32 ] [ Designated as safety issue: No ]As assessed by PDAI score
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Hyperbaric oxygen
hyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment.
Other: Hyperbaric oxygen
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01828190
|Contact: Amit Maliar, MD, PhDfirstname.lastname@example.org|
|The institute of gastroenterology and liver disease, Assaf Harofe Medical Center||Recruiting|
|Zerifin, Israel, 70800|
|Sub-Investigator: Amit Maliar, MD, PhD|
|Principal Investigator:||Haim Shirin, MD||Assaf Harofe Medical Center|