title: Randomized controlled trial of perioperative antimicrobial therapy based on the results of preoperative bile cultures in patients undergoing biliary reconstruction.
abstract: BACKGROUND
  The high frequency of surgical site infections (SSIs) after hepato-pancreato-biliary (HPB) surgery is a problem that needs to be addressed. This prospective, randomized, controlled study examined whether perioperative prophylactic use of antibiotics based on preoperative bile culture results in HPB surgery could decrease SSI.
  
  
  METHODS
  Participants comprised 126 patients who underwent HPB (bile duct, gallbladder, ampullary, or pancreatic) cancer surgery with biliary reconstruction at Hokkaido University Hospital between August 2008 and March 2013 (UMIN Clinical Trial Registry #00001278). Before surgery, subjects were randomly allocated to a targeted group administered antibiotics based on bile culture results or a standard group administered cefmetazole. The primary endpoint was SSI rates within 30 days after surgery. Secondary endpoint was SSI rates for each operative procedure.
  
  
  RESULTS
  Of the 126 patients, 124 were randomly allocated (targeted group, n = 62; standard group, n = 62). Frequency of SSI after surgery was significantly lower in the targeted group (27 patients, 43.5%) than in the standard group (44 patients, 71.0%; P = 0.002). Among patients who underwent pancreaticoduodenectomy and hepatectomy, SSI occurred significantly less frequently in the targeted group (P = 0.001 and P = 0.025, respectively).
  
  
  CONCLUSIONS
  This study demonstrated that preoperative bile culture-targeted administration of prophylactic antibiotics decreased SSIs following HBP surgery with biliary reconstruction.
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Kunishige
authors.initials: K
authors.lastname: Okamura
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Kimitaka
authors.initials: K
authors.lastname: Tanaka
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Takumi
authors.initials: T
authors.lastname: Miura
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Nakanishi
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Noji
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Tsuchikawa
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Okamura
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Shichinohe
authors.affiliation: Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hirano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D001646:Bile / Q000382:microbiology*; D001661:Biliary Tract Neoplasms / Q000601:surgery; D001662:Biliary Tract Surgical Procedures / Q000009:adverse effects / Q000379:methods; D013505:Digestive System Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008828:Microbiological Techniques; D008875:Middle Aged; D010179:Pancreas / Q000601:surgery; D010190:Pancreatic Neoplasms / Q000601:surgery; D011300:Preoperative Care; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*
chemical_list: D000890:Anti-Infective Agents
keywords: Bile culture; Hepato-biliary-pancreatic surgery; Prophylactic use of therapeutic antibiotics; Surgical site infection