Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501)
Phase 3
- Conditions
- distal gastrectomy for gastric cancer
- Registration Number
- JPRN-UMIN000000631
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 355
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of SSI
- Secondary Outcome Measures
Name Time Method