title: Randomized clinical trial of 24 versus 72 h antimicrobial prophylaxis in patients undergoing open total gastrectomy for gastric cancer.
abstract: BACKGROUND
  Open total gastrectomy carries a high risk of surgical-site infection (SSI). This study evaluated the non-inferiority of antimicrobial prophylaxis for 24 compared with 72 h after open total gastrectomy.
  
  
  METHODS
  An open-label, randomized, non-inferiority study was conducted at 57 institutions in Japan. Eligible patients were those who underwent open total gastrectomy for gastric cancer. Patients were assigned randomly to continued use of β-lactamase inhibitor for either 24 or 72 h after surgery. The primary endpoint was the incidence of SSI, with non-inferiority based on a margin of 9 percentage points and a 90 per cent c.i. The secondary endpoint was the incidence of remote infection.
  
  
  RESULTS
  A total of 464 patients (24 h prophylaxis, 228; 72 h prophylaxis, 236) were analysed. SSI occurred in 20 patients (8·8 per cent) in the 24-h prophylaxis group and 26 (11·0 per cent) in the 72-h group (absolute difference -2·2 (90 per cent c.i. -6·8 to 2·4) per cent; P < 0·001 for non-inferiority). However, the incidence of remote infection was significantly higher in the 24-h prophylaxis group.
  
  
  CONCLUSIONS
  Antimicrobial prophylaxis for 24 h after total gastrectomy is not inferior to 72 h prophylaxis for prevention of SSI. Shortened antimicrobial prophylaxis might increase the incidence of remote infection. Registration number: UMIN000001062 ( http://www.umin.ac.jp).
authors.affiliation: Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Takagane
authors.affiliation: Department of Gastrointestinal and Paediatric Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Mohri
authors.affiliation: Division of Medical Nutrition, Faculty of Healthcare, Tokyo Healthcare University, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Konishi
authors.affiliation: Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: R
authors.initials: R
authors.lastname: Fukushima
authors.affiliation: Department of Surgery, NTT Medical Centre, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Noie
authors.affiliation: Department of Surgery, Omuta City Hospital, Omuta, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Sueyoshi
authors.affiliation: Department of Surgery, Ageo Central General Hospital, Saitama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Omura
authors.affiliation: Division of Critical Care Medicine, Tokyo Medical University Hachioji Medical Centre, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Ono
authors.affiliation: Department of Gastrointestinal and Paediatric Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kusunoki
authors.affiliation: Department of Surgery, National Defence Medical College, Tokorozawa, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Mochizuki
authors.affiliation: Department of Surgery, Toho University Medical Centre, Ohashi Hospital, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Sumiyama
mesh_terms: D000368:Aged; D000667:Ampicillin / Q000008:administration & dosage; D019072:Antibiotic Prophylaxis; D004334:Drug Administration Schedule; D005260:Female; D005743:Gastrectomy; D006801:Humans; D007564:Japan / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000453:epidemiology; D013274:Stomach Neoplasms / Q000601:surgery*; D013407:Sulbactam / Q000008:administration & dosage; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*; D065093:beta-Lactamase Inhibitors / Q000008:administration & dosage
chemical_list: D065093:beta-Lactamase Inhibitors; C035444:sultamicillin; D000667:Ampicillin; D013407:Sulbactam