Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease (NCT03172143) | Clinical Trial Compass
TerminatedNot Applicable
Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease
Stopped: Accrual not met
United States2 participantsStarted 2017-08-29
Plain-language summary
The purpose of this study is to determine if taking an increased sampling of mesentery (fatty tissue next to the intestine) and lymph nodes at the time of the subject's ileocolic resection prevents a 4-6 month recurrence of Crohn's disease at the site of the new connection.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Residents of the United States
✓. Isolated ileocolic Crohn's disease without evidence of perforation
✓. Concurrent therapies with corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted
✓. All patients should have undergone a colonoscopy and CT enterography in last 3 months to assess severity of disease
✓. Have no contraindications to magnetic resonance (MR) evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
✓. Ability to comply with protocol
✓. Competent and able to provide written informed consent
✓. Medically refractory disease or inability to tolerate ongoing medical therapy
✕. Patients with concurrent disease in other locations (e.g., proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring additional operation intervention beyond an ileocolic resection
✕. Clinically significant medical conditions within the six months before administration of Mesenchymal Stem Cells (MSCs): e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient
What they're measuring
1
Number of Subjects who have Recurrence of Crohn's Disease at 6 Months