Crohn Disease
Conditions
Keywords
Ileocolic, Crohn's, Terminal ilium, Ileocecal
Brief 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.
Detailed description
Crohn's disease (CD) is a chronic inflammatory disease of the intestinal tract with an unknown etiology and an unknown cure. The characteristic transmural inflammation can progress to refractory inflammatory disease, stricturing disease, and fistulizing disease - all potential indications for surgery when medical management has been exhausted. An important tenant to remember is that surgery is not curative but is rather an adjunct to maximal medical therapy. One third of patients with CD will require a major abdominal resection within 5 years of their diagnosis, and two-thirds will ultimately require operative management at least once during the course of their disease. Unfortunately, surgery for CD is not curative and disease recurrence is common with 62% having endoscopic recurrence at six months, and 80% and 30% of patients having endoscopic and clinical recurrence, respectively, at one year. A third of these patients will require a re-operation at 10 years and up to 80% will require an additional operation by 15 years. This undoubtedly leads to an increased probability of malabsorption syndrome and decreased quality of life. A significant volume of research has been conducted in attempt to determine how to prevent postoperative recurrence of CD following an ileocolic resection. Some studies have focused on the timing of resuming postoperative medical therapy. Others have looked at surgical technique at the time of ileocolic resection including anatomic configuration of the anastomosis and performing a stapled versus handsewn anastomosis. There is recent evidence to suggest that the mesentery is actively involved in the ongoing disease process. The investigators plan to investigate if taking additional mesentery affects postoperative recurrence to support these findings.
Interventions
In this resection, the mesentery will be spared, or left in situ during resection.
PROCEDUREHigh Ligation Ileocolic Resection
In this resection, a high ligation is performed, where the feeding vessel is taken at its origin in order to take sufficient mesentery and lymph nodes with the colon specimen.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients with Crohns Disease will be randomized in a 1:1 ratio for mesenteric sparing versus high ligation of the ileocolic artery when performing an ileocolic resection for Crohn's disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Residents of the United States 2. Isolated ileocolic Crohn's disease without evidence of perforation 3. Concurrent therapies with corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted 4. All patients should have undergone a colonoscopy and CT enterography in last 3 months to assess severity of disease 5. Have no contraindications to magnetic resonance (MR) evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia 6. Ability to comply with protocol 7. Competent and able to provide written informed consent 8. Medically refractory disease or inability to tolerate ongoing medical therapy
Exclusion criteria
1. Inability to give informed consent. 2. Patients undergoing repeat ileocolic resection 3. 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 4. 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 5. Specific exclusions; a. Evidence of hepatitis B, C, or HIV 6. History of cancer including melanoma (with the exception of localized skin cancers) 7. Emergent indication for an operation 8. A resident outside the United States 9. Pregnant or breast feeding. 10. History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity 11. Inability to follow up at Mayo Clinic at 3 to 4 and 12 months for postoperative imaging and endoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects who have Recurrence of Crohn's Disease at 6 Months | 6 months after surgery | Subjects who have endoscopic or histologic evidence of recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in gross and histologic margins with each approach following surgery. | 1 year after surgery | Determine the need for restarting immunosuppressive medication within the first year postoperatively. |
Countries
United States
Outcome results
None listed