JPRN-UMIN000000631CompletedPhase 3
Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501) - OGSG-0501
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)0 sites355 target enrollmentStarted: April 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 355
Study Overview
Brief Summary
Eight patients (5%, 95% CI 2-9%) had surgical-site infections in the intraoperative group compared with 16 (9%, 5-14) in the extended group. The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 0.51 (0.22-1.16), which revealed statistically significant non-inferiority (p<0.0001).
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1.with some active or uncontrolled infection 2.neoadjuvant chemotherapy 3.PS>3 in ASA 4.administration of steroids 5.decision of ineligible patients by the researcher
Investigators
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