Peritonitis, Postoperative Complications
Conditions
Keywords
severe peritonitis, SSI, lower digestive tract surgery, Severe peritonitis after lower digestive tract surgery
Brief summary
The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.
Interventions
DRUGintravenous immunoglobulin
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow. 1. Patients with \>=38 degrees C, \>=15,000/mm3 or \<=3,000/mm3 of WBC and \>=10mg/dL of CRP 2. Patients who have no abscess on the abdominal image 3. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement 4. Patients who are 20 years old or older 5. Patients who have signed the agreement for participation in this study
Exclusion criteria
1. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products 2. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products 3. Patients who were administered immunoglobulin within 1 month before entry 4. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement 5. Patients with IgA deficiency 6. Patients with hereditary fructose intolerance 7. Patients with history of allergy or adverse effect for antibacterial agents 8. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study 9. Patients who are or could be pregnant 10. Patients who have noninfectious fever, fungal infection or viral illness 11. Other patients who are judged to be inadequate to participate in this study by their physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical efficacy | at day 7 |
Secondary
| Measure | Time frame |
|---|---|
| clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms | at day 3 and at the end of test drug administration, |
Countries
Japan
Outcome results
None listed