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)
المؤلفون المشاركون
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
المصدر
Gastroenterology Research and Practice
العدد
المجلد 2017، العدد 2017 (31 ديسمبر/كانون الأول 2017)، ص ص. 1-6، 6ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2017-06-05
دولة النشر
مصر
عدد الصفحات
6
التخصصات الرئيسية
الملخص 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.
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1156694
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر