title: Perioperative selective decontamination of the digestive tract and standard antibiotic prophylaxis versus standard antibiotic prophylaxis alone in elective colorectal cancer patients.
abstract: BACKGROUND
  Infectious complications and especially anastomotic leakage (AL) severely impede the recuperation of patients following colorectal cancer (CRC) surgery. When the normal gut barrier fails, as in AL, pathogenic microorganisms can enter the circulation and may cause severe sepsis which is associated with substantial mortality. Moreover, AL has a negative impact on the CRC prognosis. Selective decontamination of the digestive tract (SDD) employs oral nonabsorbable antibiotics to eradicate pathogenic microorganisms before elective tumour resection.
  
  
  METHODS
  In this multicentre randomised clinical trial, perioperative SDD in addition to standard antibiotic prophylaxis is compared with standard antibiotic prophylaxis alone in patients with CRC who undergo elective surgical resection with a curative intent. The SDD regimen consists of colistin, tobramycin and amphotericin B. The primary objectives of this randomised clinical trial are to evaluate if perioperative SDD reduces the incidence of clinical AL and its septic consequences as well as other infectious complications. A main secondary objective is improvement of the cancer-free survival. A total of 762 patients will be included in total for sufficient power.
  
  
  CONCLUSIONS
  It is hypothesised that SDD will reduce clinical AL thereby reducing the morbidity and the mortality in CRC patients.
  
  
  BACKGROUND
  The trial is investigator-initiated, investigator-driven and supported by the Dutch Digestive Foundation (WO 11-06) and the private Posthumus Meyes Fund.
  
  
  BACKGROUND
  The trial is registered at ClinicalTrials.gov: NCT01740947.
authors.affiliation: Department of Surgery, VU Medical Centre, De Boelelaan 117, 1081 HV Amsterdam, The Netherlands. j.bonjer@vumc.nl.
authors.forename: Gabor S A
authors.initials: GS
authors.lastname: Abis
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Oosterling
authors.forename: Hein B A C
authors.initials: HB
authors.lastname: Stockmann
authors.forename: Gerben J
authors.initials: GJ
authors.lastname: van der Bij
authors.forename: Marjolein
authors.initials: M
authors.lastname: van Egmond
authors.forename: Christina M J E
authors.initials: CM
authors.lastname: Vandenbroucke-Grauls
authors.forename: H Jaap
authors.initials: HJ
authors.lastname: Bonjer
mesh_terms: D000666:Amphotericin B / Q000627:therapeutic use*; D057868:Anastomotic Leak; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D003091:Colistin / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000601:surgery*; D003666:Decontamination / Q000379:methods*; D004064:Digestive System / Q000382:microbiology; D017558:Elective Surgical Procedures; D006801:Humans; D019990:Perioperative Care / Q000379:methods*; D014031:Tobramycin / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D000666:Amphotericin B; D014031:Tobramycin; D003091:Colistin