Crohn'
Conditions
Interventions
In the intervention group, sivelestat sodium will be continuously administered intravenously at 4.8 mg/kg from introduction of anesthesia until a maximum of 2 days after surgery.
In the control group,
Sponsors
Department of Surgery 2,Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 16 years old or older at the time of obtaining consent Patients who give written consent of their own free will after receiving a sufficient explanation of the study and fully understanding the study before participation.
Exclusion criteria
Exclusion criteria: Medical history of hypersensitivity to sivelestat Age below 16 years old at the time of obtaining consent Judgment of ineligibility to be a subject by the principle investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Changes in T lymphocytes and inflammatory cytokines (IL-6 and IL-10) Safety evaluation (adverse events and abnormal laboratory test values) | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection | — |
Countries
Japan
Contacts
Public ContactMichio Itabashi
Tokyo Women's Medical University Department of Surgery 2
Outcome results
None listed