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)
Joint Authors
Jeong, Oh
Park, Young Kyu
Jung, Mi Ran
Ryu, Seong Yeob
Kim, Min Chan
Kim, Ki Han
Ryu, Seung Wan
Kwon, In Gyu
Son, Young Gil
Source
Gastroenterology Research and Practice
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-06-05
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
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% confidence interval=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.
American Psychological Association (APA)
Jeong, Oh& Jung, Mi Ran& Ryu, Seong Yeob& Park, Young Kyu& Kim, Min Chan& Kim, Ki Han…[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 (KSWEET-01 Study). Gastroenterology Research and Practice،Vol. 2017, no. 2017, pp.1-6.
https://search.emarefa.net/detail/BIM-1156694
Modern Language Association (MLA)
Jeong, Oh…[et al.]. 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). Gastroenterology Research and Practice No. 2017 (2017), pp.1-6.
https://search.emarefa.net/detail/BIM-1156694
American Medical Association (AMA)
Jeong, Oh& Jung, Mi Ran& Ryu, Seong Yeob& Park, Young Kyu& Kim, Min Chan& Kim, Ki Han…[et al.]. 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). Gastroenterology Research and Practice. 2017. Vol. 2017, no. 2017, pp.1-6.
https://search.emarefa.net/detail/BIM-1156694
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1156694