title: The prevention of anastomotic leakage after total gastrectomy with local decontamination. A prospective, randomized, double-blind, placebo-controlled multicenter trial.
abstract: OBJECTIVE
  A prospective, randomized, double-blind, placebo controlled multicenter trial was undertaken in 205 patients treated with total gastrectomy for gastric malignancies to evaluate whether local antimicrobial measures reduce the incidence of esophagojejunal anastomotic leakage.
  
  
  BACKGROUND
  Anastomotic leakage of the esophagojejunostomy is always a septic complication of total gastrectomy for gastric malignancies, but it never has been attempted to prevent this complication with the administration of topical antimicrobial agents during the critical phase of anastomotic wound healing.
  
  
  METHODS
  To evaluate the efficacy and safety of topical decontamination, the study was carried out as a prospective, randomized, double-blind and placebo-controlled clinical multicenter trial in patients with total gastrectomy for gastric cancer. Patients received either placebo or decontamination with polymyxin B (100 mg), tobramycin (80 mg), vancomycin (125 mg), and amphotericin B (500 mg) four times per day orally from the day before the operation until the seventh postoperative day. All patients received a perioperative intravenous prophylaxis with cefotaxime 2 x 2 g. Other interventions including the administration of antibiotics and fluids, were not affected by the study protocol.
  
  
  RESULTS
  Of 260 patients who were randomized, total gastrectomy was not carried out in 55 patients. They dropped out of the study. Patients receiving an esophagojejunostomy were observed until day 42, when they were discharged from the clinic or died. An intention-to-treat analysis of the data was carried out. Among the 103 recipients of placebo, there were 11 (10.6%) with an anastomotic leakage of the esophagojejunostomy, and among the 102 recipients of decontamination, there were 3 (2.9%) with an anastomotic leakage of the esophagojejunostomy (p = 0.0492). Pulmonary infections were observed in 23 patients (22.3%) receiving placebo and in 9 patients (8.8%) who were decontaminated (p = 0.02). There were 11 deaths (10.6%) among the recipients of placebo and 5 deaths (4.9%) among the recipients of decontamination (p = 0.1).
  
  
  CONCLUSIONS
  Decontamination with polymyxin, tobramycin, vancomycin, and amphotericin B during anastomotic wound healing is safe and effective in the prevention of esophagojejunal anastomotic leakage after total gastrectomy.
authors.affiliation: Department of Surgery, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: H M
authors.initials: HM
authors.lastname: Schardey
authors.forename: U
authors.initials: U
authors.lastname: Joosten
authors.forename: U
authors.initials: U
authors.lastname: Finke
authors.forename: K H
authors.initials: KH
authors.lastname: Staubach
authors.forename: R
authors.initials: R
authors.lastname: Schauer
authors.forename: A
authors.initials: A
authors.lastname: Heiss
authors.forename: A
authors.initials: A
authors.lastname: Kooistra
authors.forename: H G
authors.initials: HG
authors.lastname: Rau
authors.forename: R
authors.initials: R
authors.lastname: Nibler
authors.forename: S
authors.initials: S
authors.lastname: Lüdeling
authors.forename: K
authors.initials: K
authors.lastname: Unertl
authors.forename: G
authors.initials: G
authors.lastname: Ruckdeschel
authors.forename: H
authors.initials: H
authors.lastname: Exner
authors.forename: F W
authors.initials: FW
authors.lastname: Schildberg
mesh_terms: D000368:Aged; D000666:Amphotericin B / Q000627:therapeutic use; D000714:Anastomosis, Surgical; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis; D003666:Decontamination; D004311:Double-Blind Method; D005260:Female; D005743:Gastrectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011113:Polymyxins / Q000627:therapeutic use; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D014031:Tobramycin / Q000627:therapeutic use; D014640:Vancomycin / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D011113:Polymyxins; D014640:Vancomycin; D000666:Amphotericin B; D014031:Tobramycin