계명대학교 의학도서관 Repository

Multicenter phase 2 study about the safety of no antimicrobial prophylaxis use in low risk patients undergoing laparoscopic distal gastrectomy for gastric carcinoma

Metadata Downloads
Affiliated Author(s)
류승완손영길
Alternative Author(s)
Son, Young GilRyu, Seung Wan
Journal Title
Gastroenterology Research and Practice
ISSN
1687-6121
Issued Date
2017
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% ). 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 () 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.
Department
Dept. of Surgery (외과학)
Publisher
School of Medicine
Citation
Oh Jeong et al. (2017). Multicenter phase 2 study about the safety of no antimicrobial prophylaxis use in low risk patients undergoing laparoscopic distal gastrectomy for gastric carcinoma. Gastroenterology Research and Practice, 2017, 8928353–8928353. doi: 10.1155/2017/8928353
Type
Article
ISSN
1687-6121
DOI
10.1155/2017/8928353
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32404
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
공개 및 라이선스
  • 공개 구분공개
파일 목록

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.