Background. Recent studies have shown a lower risk of surgical site infections (SSI) after laparoscopic distal gastrectomy compared\nto open surgery. This is a phase 2 study aiming to determine the incidence of SSI after laparoscopic distal gastrectomy without using\nantimicrobial prophylaxis (AMP). Methods. cT1N0 gastric cancers that were subject to laparoscopic distal gastrectomy were\nenrolled. Based on the unacceptable SSI incidence of ââ?°Â¥12.5% and the target SSI incidence of ââ?°Â¤5%, 105 patients were enrolled\nwith an Ã?± of 0.05 and a power of 80% (ClinicalTrials.gov, NCT02200315). Results. In intention-to-treat analysis, patients did not\nreach the target SSI rate (12.4%, 95% confidence interval = 6 8%ââ?¬â??19 8%). Of patients, 44 patients had a protocol violation, such\nas extended lymph node dissection (LND) or inappropriate nonpharmacological SSI prevention measures. Per-protocol analysis\nexcluding these patients (n = 61) showed a SSI rate of 4.9%, which was within the target SSI range. Multivariate analysis revealed\nthat extracorporeal anastomosis and extended LND were independent risk factors for SSI. Conclusions. This study failed to\nreach the target SSI rate without using AMP. However, per-protocol analysis suggests that no AMP might be feasible when\nlimited LND and adequate SSI prevention measures were performed.
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