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Clinical Trials/JPRN-UMIN000000631
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

Sponsor
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

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