Spondyloarthropathies Clinical Trial
— SPONDILENDOOfficial title:
The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon
or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will
develop. Lesions of the bowel could also be present in the SA patients because of the
potential injury posed by the NSAIDS, a common used medication in this setting.
It is the bowel involvement in patients with SA that we propose to characterize, partly
because there are scant communicated data in the medical literature, especially regarding
small bowel lesions.
Status | Completed |
Enrollment | 65 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - signing of the inform consent - subjects 18 years old or more - patients with spondyloarthropathy as defined by the Amor criteria Exclusion Criteria: - presumed intestinal obstruction - impaired deglutition - cardiac pace-makers present - pregnancy - pelvic or abdominal radiotherapy anytime in the past - major abdominal surgery anytime in the past - major comorbidities which could represent a contraindication to a surgical abdominal intervention |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Romania | Gastroenterology Department, Colentina Clinical Hospital | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Carol Davila University of Medicine and Pharmacy | Clinical Hospital Colentina, EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH |
Romania,
Rimbas M, Marinescu M, Voiosu MR, Baicus CR, Caraiola S, Nicolau A, Nitescu D, Badea GC, Pârvu MI. NSAID-induced deleterious effects on the proximal and mid small bowel in seronegative spondyloarthropathy patients. World J Gastroenterol. 2011 Feb 28;17(8) — View Citation
Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with bowel lesions | July 2012 | No | |
Secondary | Correlation of the bowel lesions with patient status | July 2012 | No |
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