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

Imamura, Hiroshi; Kurokawa, Yukinori; Tsujinaka, Toshimasa; Inoue, Kentaro; Kimura, Yutaka; Iijima, Shöhei; Shimokawa, Toshio; Furukawa, Hiroshi

doi:10.1016/s1473-3099(11)70370-x

Cited by 36 publications

(46 citation statements)

References 24 publications

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“…The baseline patient and operative characteristics are shown in Table 1. The results concerning the detailed patient characteristics can be referred to in the previously reported data [4] The overall SSI rate for open distal gastrectomy was 7 % (24/355), 5 % (8/176) for the standard group, and 9 % (16/179) for the extended group. Six patients had superficial type SSIs and 18 had organ/space type SSIs.…”

Section: Resultsmentioning

confidence: 81%

“…Analysis was based on the intention-to-treat principle. The results concerning the endpoints and other details of the study design have been reported [4].…”

Section: Outline Of Ogsg 0501 As the Original Trialmentioning

confidence: 99%

“…Previously, we conducted a phase 3 randomized controlled trial (RCT), the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) 0501, to compare standard antimicrobial prophylaxis administration versus extended antimicrobial prophylaxis administration in patients receiving open distal gastrectomy for gastric cancer, and the results concerning the primary and secondary endpoints have been reported [4]. Because the OGSG 0501 trial was based on a single elective surgical procedure performed under uniform conditions, it is worthwhile to analyze the risk factors associated with SSIs following gastrectomy, using the data of the OGSG 0501.…”

Section: Introductionmentioning

confidence: 99%

“…The patients were monitored for SSI according to the NNIS criteria until 30 days after the operation at each institution. The definitions of SSI are listed below [4,5].…”

Section: Introductionmentioning

confidence: 99%

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Overweight is a risk factor for surgical site infection following distal gastrectomy for gastric cancer

et al. 2012

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Background Our objective was to assess the risk factors for surgical site infections (SSIs) in gastric surgery using the results of the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) 0501 phase 3 trial. Methods The OGSG 0501 trial was conducted to compare standard prophylactic antibiotic administration versus extended prophylactic antibiotic administration in 355 patients who underwent open distal gastrectomy for gastric cancer. Various risk factors associated with the incidence of SSI following gastrectomy were analyzed from the results of this multi-institutional randomized controlled trial. Results Among the 355 patients, there were 24 SSIs, for an overall SSI rate of 7 %. Multivariate analysis using eight baseline factors (administration of antibiotics, age, sex, body mass index [BMI], prognostic nutritional index, tumor stage, lymph node dissection, reconstructive method) identified that BMI C25 kg/m 2 was an independent risk factor for the occurrence of SSI (odds ratio 2.82; 95 % confidence interval [CI] 1.05-7.52; P = 0.049). BMI also showed significant relationships with the volume of blood loss and the operation time (P = 0.001 and P \ 0.001, respectively). Conclusion Compared with patients of normal weight, overweight patients had a significantly higher risk of SSI after distal gastrectomy for cancer.

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Section: Resultsmentioning

confidence: 81%

“…Analysis was based on the intention-to-treat principle. The results concerning the endpoints and other details of the study design have been reported [4].…”

Section: Outline Of Ogsg 0501 As the Original Trialmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…The patients were monitored for SSI according to the NNIS criteria until 30 days after the operation at each institution. The definitions of SSI are listed below [4,5].…”

Section: Introductionmentioning

confidence: 99%

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Overweight is a risk factor for surgical site infection following distal gastrectomy for gastric cancer

et al. 2012

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“…According to the National Healthcare Safety Network of the CDC in the USA, SSIs at primary incision sites occurred following 2.2 % of all gastric surgery procedures in 2006-2008 [2], whereas the Japanese Healthcare Associated Infections Surveillance [3] reported a figure of 3.5 % in 2012 in Japan. The Osaka Gastrointestinal Cancer Chemotherapy Study Group has performed randomized controlled trials (RCTs) in which the primary end points were incidences of SSIs: it found that superficial incisional SSIs occurred in 15 of 231 patients (6.5 %) following total gastrectomy [4] and in six of 355 patients (1.7 %) following distal gastrectomy [5]. Although skin and fascia closing methods were not controlled, these data suggest that total gastrectomy causes more superficial incisional SSIs than does distal gastrectomy.…”

Section: Introductionmentioning

confidence: 99%

Risk factors for superficial incisional surgical site infection after gastrectomy: analysis of patients enrolled in a prospective randomized trial comparing skin closure methods

et al. 2015

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Background Surgical site infection is one of the commonest complications of gastrointestinal surgery. The nature of surgical procedures and wound closure methods may influence the incidence of superficial incisional surgical site infection. Patients enrolled in a prospective randomized controlled trial comparing skin closure methods are the best subjects for analyzing surgical site infection risk.Method From a cohort of 1080 patients who had been enrolled in our previous randomized controlled trial, data for 685 patients who had undergone elective open total gastrectomy or distal gastrectomy for gastric cancer were extracted. The incidences of superficial incisional surgical site infection after total gastrectomy and distal gastrectomy were compared and risk factors for superficial incisional surgical site infection were investigated by univariate analyses using logistic regression models. Results In all, 42 patients (6.1 %) developed superficial incisional surgical site infections after gastrectomy; 15 of 288 patients (5.2 %) developed these infections after total gastrectomy, and 27 of 397 patients (6.8 %) developed these infections after distal gastrectomy-these differences are not significant. According to univariate analysis, age (75 years or older or younger than 75 years) was the only risk factor for superficial incisional surgical site infections (P = 0.049). There was a tendency for the incidence of superficial incisional surgical site infection to increase in parallel with age. Conclusion The incidence of superficial incisional surgical site infection did not differ between total gastrectomy and distal gastrectomy. Advanced age was the only identified risk factor for superficial incisional surgical site infections after gastrectomy.

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Dual‐center randomized clinical trial exploring the optimal duration of antimicrobial prophylaxis in patients undergoing pancreaticoduodenectomy following biliary drainage

Yamamoto

Satoi

Fujii

et al. 2018

Annals of Gastroent Surgery

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ObjectivesThe aim of this dual‐center randomized controlled trial was to determine the optimal duration of antimicrobial prophylaxis in patients treated with pancreaticoduodenectomy (PD) who underwent preoperative biliary drainage (PBD) but were without cholangitis.BackgroundSome reports showed that PBD in patients undergoing pancreatectomy increased the rate of perioperative complications. However, no clinical trial has evaluated the optimal duration of antimicrobial prophylaxis with a focus on patients who underwent PD following PBD.MethodsA total of 82 patients who underwent PD between March 2012 and December 2016 were randomly assigned to either a 1‐day group (n = 40), in which cefozopran (CZOP) as antimicrobial prophylaxis was given only on the day of surgery, or a 5‐day group (n = 42), in which CZOP was given for 5 consecutive days beginning on the day of surgery. We evaluated the incidence of infectious and other complications after PD.ResultsOutcomes were significantly better in the 1‐day group compared with the 5‐day group (P < 0.05) in terms of the incidence of overall infectious complications (15% vs 36%, respectively), intra‐abdominal abscess (3% vs 21%, respectively), clinically relevant postoperative pancreatic fistula (8% vs 24%, respectively), and Clavien‐Dindo grade III‐V complications (10% vs 31%, respectively). Duration of postoperative hospital stay was significantly shorter in the 1‐day group (10 days vs 15 days, P = 0.018). Anaerobic bacteria and methicillin‐resistant cocci were isolated from the drainage fluid only among patients in the 5‐day group.ConclusionSingle‐day prophylactic use of CZOP is appropriate for patients who undergo PD following PBD without preoperative cholangitis.

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

Cited by 36 publications

References 24 publications

Overweight is a risk factor for surgical site infection following distal gastrectomy for gastric cancer

Overweight is a risk factor for surgical site infection following distal gastrectomy for gastric cancer

Risk factors for superficial incisional surgical site infection after gastrectomy: analysis of patients enrolled in a prospective randomized trial comparing skin closure methods

Dual‐center randomized clinical trial exploring the optimal duration of antimicrobial prophylaxis in patients undergoing pancreaticoduodenectomy following biliary drainage

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