MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)

Korábbi kezelés

• Patients undergoing repeat ileocolic resection
• Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection.
• Clinically significant medical conditions within the six months before surgery: 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.
• History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity

Más betegség

• Patients with >30 cm of terminal ileal disease
• Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve
• Specific exclusions; Evidence of hepatitis B, C, or HIV
• History of cancer including melanoma (with the exception of localized skin cancers)

Életkor

• Patients less than 18 years of age

Egyéb

• Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy
• Emergent indication for an operation
• Pregnant or breast feeding.
• Inability to follow up at respective sites for the primary endpoint

• Males and females 18-65 years of age.
• Isolated ileocolic Crohn's disease of <30 cm in length
• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
• Ability to comply with protocol
• Competent and able to provide written informed consent
• Medically refractory disease or inability to tolerate ongoing medical therapy