Intraoperative versus extended antimicrobial prophylaxis after gastric cancer surgery: a phase 3, open-label, randomised controlled, non-inferiority trial

Abstract The duration of antimicrobial prophylaxis in gastric cancer surgery is not yet established. This prospective randomized study was performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of surgical-site infection in gastric cancer surgery. Three hundred twenty-five patients undergoing elective resection for gastric cancer were randomized to receive only single-dose cefazolin (1 g) during surgery (single-dose group) or an additional 5 doses every 12 hours postoperatively (multiple-dose group). The overall incidence of surgical-site infections was 9.1% in the single-dose group and 6.2% in the multiple-dose group [difference (95% confidence interval): −2.9% (−5.9%–0.0%)]. Multivariate logistic regression analysis identified blood loss, being overweight, and advanced age as significant independent risk factors for surgical-site infection. Single-dose antimicrobial prophylaxis seemed to be acceptable, and choosing multiple-dose prophylaxis may have little impact on the prevention of surgical-site infections in elective gastric cancer surgery.

Download Full-text

Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial

The Lancet ◽

10.1016/s0140-6736(11)61873-4 ◽

2012 ◽

Vol 379 (9813) ◽

pp. 315-321 ◽

Cited By ~ 784

Author(s):

Yung-Jue Bang ◽

Young-Woo Kim ◽

Han-Kwang Yang ◽

Hyun Cheol Chung ◽

Young-Kyu Park ◽

...

Keyword(s):

Gastric Cancer ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Open Label ◽

Phase 3 ◽

D2 Gastrectomy ◽

Randomised Controlled

Download Full-text

Is 72 h of antimicrobial prophylaxis better than 24 h in elective gastric cancer surgery?

TURKISH JOURNAL OF MEDICAL SCIENCES ◽

10.3906/sag-1804-1 ◽

2018 ◽

Vol 48 (6) ◽

pp. 1135-1140

Author(s):

Xiang XIA ◽

Gang ZHAO ◽

Wei LING ◽

Fengrong YU

Keyword(s):

Gastric Cancer ◽

Antimicrobial Prophylaxis ◽

Cancer Surgery ◽

Gastric Cancer Surgery ◽

Better Than

Download Full-text

Reporting of outcomes in gastric cancer surgery trials: a systematic review

BMJ Open ◽

10.1136/bmjopen-2018-021796 ◽

2018 ◽

Vol 8 (10) ◽

pp. e021796 ◽

Cited By ~ 8

Author(s):

Bilal Alkhaffaf ◽

Jane M Blazeby ◽

Paula R Williamson ◽

Iain A Bruce ◽

Anne-Marie Glenny

Keyword(s):

Gastric Cancer ◽

Core Outcome Set ◽

Cancer Surgery ◽

Measurement Instruments ◽

International Consensus ◽

Surgical Interventions ◽

Gastric Cancer Surgery ◽

Study Protocols ◽

Patient Reported ◽

Randomised Controlled

BackgroundThe development of clinical guidelines for the surgical management of gastric cancer should be based on robust evidence from well-designed trials. Being able to reliably compare and combine the outcomes of these trials is a key factor in this process.ObjectivesTo examine variation in outcome reporting by surgical trials for gastric cancer and to identify outcomes for prioritisation in an international consensus study to develop a core outcome set in this field.Data sourcesSystematic literature searches (Evidence Based Medicine, MEDLINE, EMBASE, CINAHL, ClinicalTrials.gov and WHO ICTRP) and a review of study protocols of randomised controlled trials, published between 1996 and 2016.InterventionTherapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorised into groups (outcome themes) and examined for definitions and measurement instruments.ResultsOf 1919 abstracts screened, 32 trials (9073 participants) were identified. A total of 749 outcomes were reported of which 96 (13%) were accompanied by an attempted definition. No single outcome was reported by all trials. ‘Adverse events’ was the most frequently reported ‘outcome theme’ in which 240 unique terms were described. 12 trials (38%) classified complications according to severity, with 5 (16%) using a formal classification system (Clavien-Dindo or Accordion scale). Of 27 trials which described ‘short-term’ mortality, 15 (47%) used one of five different definitions. 6 out of the 32 trials (19%) described ‘patient-reported outcomes’.ConclusionReporting of outcomes in gastric cancer surgery trials is inconsistent. A consensus approach to develop a minimum set of well-defined, standardised outcomes to be used by all future trials examining therapeutic surgical interventions for gastric cancer is needed. This should consider the views of all key stakeholders, including patients.

Download Full-text

A randomized phase III trial to determine the efficacy of postoperative antimicrobial prophylaxis in gastric cancer surgery (OGSG0501)

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e15576 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e15576-e15576

Author(s):

K. Inoue ◽

H. Imamura ◽

Y. Kimura ◽

K. Fujitani ◽

Y. Miyake ◽

...

Keyword(s):

Gastric Cancer ◽

Surgical Site Infection ◽

Infection Rate ◽

Distal Gastrectomy ◽

Antimicrobial Prophylaxis ◽

Cancer Surgery ◽

Phase Iii ◽

Site Infection ◽

Phase Iii Trial ◽

Gastric Cancer Surgery

e15576 Background: In Japan, antimicrobial prophylaxis (AMP) is typically administered for 3 to 4 days postoperatively in gastric cancer surgery. This far exceeds the recommended 24h or less laid out by the Centers for Disease Control (CDC) guidelines for the prevention of surgical-site infections, after a clean-contaminated operation. Methods: A multicenter randomized phase III trial was designed to evaluate the effect of postoperative AMP in gastric cancer surgery. Patients (pts) were required to have histologically proven gastric cancer which was curable by distal gastrectomy, be classifiable as ASA 1 or 2, and have adequate organ function. Pts were randomized to: (A) perioperative AMP (cefazolin 1g, at <30min before incision, every 3h intraoperative supplements) plus postoperative AMP (cefazolin 1g, twice daily for 2 postoperative days) or (B) perioperative AMP alone. Pts were stratified by institution and ASA. The primary endpoint was the incidence of surgical site infection (SSI). With 171 pts per arm, this study had 80% power to demonstrate non-inferiority with 5% margin of peri-AMP alone and 0.05 1-sided alpha. Results: 355 patients were recruited (A: 179, B: 176) in 7 centers between June 2005 and December 2007. The surgical-site infection rate was 9.0 percent (16 of 178) for peri-/post AMP and 4.5 percent (8 of 176) for peri-AMP alone, with no significant differences (Fisher's exact test: P=0.14, RR=1.98 [95%CI, 0.89–4.44]), but showing a significant non-inferiority (P<0.001). The remote site infection rate was 3.4 percent (6 of 178) for peri-/post AMP and 5.1 percent (9 of 175) for peri-AMP alone, with no significant differences (P=0.44, RR=0.66 [95%CI, 0.25- 1.70]). Conclusions: This multicenter randomized phase III trial confirms that postoperative AMP is unnecessary in patients undergoing distal gastrectomy for gastric cancer. No significant financial relationships to disclose.

Download Full-text