Crohn'
Conditions
Interventions
Patients are randomly divided into two groups, groups treated with or without infliximab by staffs of Keio Clinical Research Center at 2 to 4 weeks after surgery. Patients receive infliximab 5 mg/kg
Sponsors
Clinical Research Group of inflammatory bowel disease in Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are enrolled within 4 weeks of resection of macroscopically diseased bowel with anastomosis between normal ileum and colon (ileocolonic anastomosis) or colon and colon (colocolonic anastomosis). Any type of anastomosis is permitted. Surgeons are required to confirm that no macroscopic lesion is left in the remnant intestine except for the strictureplasty sites. Number of strictureplasty must be less than three and the type of plasty is restricted to Heineke-Mickulicz type.
Exclusion criteria
Exclusion criteria: Exclusion criteria include 1) 3 or more surgeries in the past, 2) presence of the stoma, 3) multiple anastomosis, 4) 4 or more strictureplasties, or 5) other types of strictureplasty excepting Heineke-Mickulicz type. A patient is also excluded when doctors in charge of the patient consider that exclusion of the patient is preferable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presense or absense of endoscopic recurrence at the anastomotic site after 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic grade evaluated with Rutgeerts's grading scale after 24 months. Crohn's disease activity index point after 24 months. | — |
Countries
Japan
Contacts
Public ContactHaneda Sho
Tohoku University Graduate School of Medicine Department of Surgery, Division of Biological Regulation
Outcome results
None listed