Multicenter Phase 2 Study about the Safety of No Antimicrobial Prophylaxis Use in Low-Risk Patients Undergoing Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-01 Study). (5th June 2017)

• Record Type: Journal Article
• Authors: Jeong, Oh; Jung, Mi Ran; Ryu, Seong Yeob; Park, Young-Kyu; Kim, Min Chan; Kim, Ki Han; Ryu, Seung Wan; Kwon, In Gyu; Son, Young Gil
• Other Names: hubner martin Academic Editor.
• Is Part Of: Gastroenterology research and practice. Volume 2017(2017)
• Publication Date: 2017-06-05
• Subjects: Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; 616.33005
• DOI: 10.1155/2017/8928353
• Languages: English
• ISSNs: 1687-6121

Abstract

Abstract : Background . Recent studies have shown a lower risk of surgical site infections (SSI) after laparoscopic distal gastrectomy compared to open surgery. This is a phase 2 study aiming to determine the incidence of SSI after laparoscopic distal gastrectomy without using antimicrobial prophylaxis (AMP). Methods . cT1N0 gastric cancers that were subject to laparoscopic distal gastrectomy were enrolled. Based on the unacceptable SSI incidence of ≥12.5% and the target SSI incidence of ≤5%, 105 patients were enrolled with an α of 0.05 and a power of 80% (ClinicalTrials.gov, NCT02200315). Results . In intention-to-treat analysis, patients did not reach the target SSI rate (12.4%, 95% c o n f i d e n c e i n t e r v a l = 6.8 % – 19.8 % ). Of patients, 44 patients had a protocol violation, such as extended lymph node dissection (LND) or inappropriate nonpharmacological SSI prevention measures. Per-protocol analysis excluding these patients (n = 61 ) showed a SSI rate of 4.9%, which was within the target SSI range. Multivariate analysis revealed that extracorporeal anastomosis and extended LND were independent risk factors for SSI. Conclusions . This study failed to reach the target SSI rate without using AMP. However, per-protocol analysis suggests that no AMP might be feasible when limited LND and adequate SSI prevention measures were performed.