title: Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).
abstract: BACKGROUND
  Acute calculous cholecystitis represents one of the most common complications of cholelithiasis. While laparoscopic cholecystectomy is the standard treatment in mild and moderate forms, the need for antibiotic therapy after surgery remains undefined. The aim of the randomised controlled Cholecystectomy Antibiotic Randomised Trial (CHART) is therefore to assess if there are benefits in the use of postoperative antibiotics in patients with mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy is performed.
  
  
  METHODS
  A single-centre, double-blind, randomised trial. After screening for eligibility and informed consent, 300 patients admitted for acute calculus cholecystitis will be randomised into two groups of treatment, either receiving amoxicillin/clavulanic acid or placebo for 5 consecutive days. Postoperative evaluation will take place during the first 30 days. Postoperative infectious complications are the primary end point. Secondary end points are length of hospital stay, readmissions, need of reintervention (percutaneous or surgical reinterventions) and overall mortality. The results of this trial will provide strong evidence to either support or abandon the use of antibiotics after surgery, impacting directly in the incidence of adverse events associated with the use of antibiotics, the emergence of bacterial resistance and treatment costs.
  
  
  BACKGROUND
  This study and informed consent sheets have been approved by the Research Projects Evaluating Committee (CEPI) of Hospital Italiano de Buenos Aires (protocol N° 2111).
  
  
  RESULTS
  The results of the trial will be reported in a peer-reviewed publication.
  
  
  BACKGROUND
  NCT02057679.
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Pablo
authors.initials: P
authors.lastname: Pellegrini
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Campana
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Agustín
authors.initials: A
authors.lastname: Dietrich
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Jeremías
authors.initials: J
authors.lastname: Goransky
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Juan
authors.initials: J
authors.lastname: Glinka
authors.affiliation: Department of Internal Medicine and Statistics, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Diego
authors.initials: D
authors.lastname: Giunta
authors.affiliation: Department of Internal Medicine and Infectology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Laura
authors.initials: L
authors.lastname: Barcan
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alvarez
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Oscar
authors.initials: O
authors.lastname: Mazza
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Sánchez Claria
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Martin
authors.initials: M
authors.lastname: Palavecino
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Arbues
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Victoria
authors.initials: V
authors.lastname: Ardiles
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Eduardo
authors.initials: E
authors.lastname: de Santibañes
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Juan
authors.initials: J
authors.lastname: Pekolj
authors.affiliation: Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Martin
authors.initials: M
authors.lastname: de Santibañes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy*; D017081:Cholecystectomy, Laparoscopic; D041881:Cholecystitis, Acute / Q000188:drug therapy* / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents
keywords: INFECTIOUS DISEASES; antibiotics; cholecystitis; laparoscopy; postoperative