Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Isolated ileocolic Crohn's disease without evidence of perforation.
  • Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
  • All patients should have undergone a colonoscopy and CT or MR enterography within the last 2 weeks to assess severity of disease.
  • Ability to comply with protocol.
  • Competent and able to provide written informed consent.
  • Medically refractory disease or inability to tolerate ongoing medical therapy.

Exclusion Criteria: 

  • Inability to give informed consent.
  • Patients less than 18 years of age and older than 65.
  • 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 additional operation intervention 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.
  • Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve.
  • Patients with > 30 cm of terminal ileal disease.
  • Patients with evidence of hepatitis B, C, or HIV.
  • History of cancer including melanoma (with the exception of localized skin cancers).
  • Emergent indication for an operation.
  • Pregnant or breast feeding.
  • History of clinically significant auto-immunity (other than Crohn’s disease) or any previous example of fat-directed autoimmunity.
  • Inability to follow up at Mayo Clinic Rochester between 3-4 months and at 12 months for post-operative imaging and colonoscopy.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Amy Lightner, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20323050

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