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Sponsored by: |
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group |
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Information provided by: | Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group |
ClinicalTrials.gov Identifier: | NCT00511212 |
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.
Condition | Intervention |
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Peritonitis Postoperative Complications |
Drug: intravenous immunoglobulin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract |
Estimated Enrollment: | 60 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2009 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.
Exclusion Criteria:
Contact: Mitsugu Sekimoto, MD, PhD | +81-6-6879-3251 ext 3251 | sekimoto@surg2.med.osaka-u.ac.jp |
Contact: Masataka Ikeda, MD, PhD | +81-6-6879-3251 ext 3251 | mikeda@surg2.med.osaka-u.ac.jp |
Japan, Osaka | |
Osaka University Hospital | Recruiting |
Suita, Osaka, Japan, 565-0871 | |
Contact: Mitsugu Sekimoto, MD, PhD +81-6-6879-3251 ext 3251 sekimoto@surg2.med.osaka-u.ac.jp | |
Contact: Masataka Ikeda, MD, PhD +81-6-6879-3251 ext 3251 mikeda@surg2.med.osaka-u.ac.jp |
Study Chair: | Morito Monden, MD, PhD | Multicenter Clinical Study Group of Osaka |
Study ID Numbers: | MCSGO-0701 |
Study First Received: | August 1, 2007 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00511212 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
severe peritonitis SSI lower digestive tract surgery Severe peritonitis after lower digestive tract surgery |
Antibodies Digestive System Diseases Postoperative Complications Immunoglobulins, Intravenous |
Peritonitis Peritoneal Diseases Rho(D) Immune Globulin Immunoglobulins |
Pathologic Processes Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |