title: Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial.
abstract: OBJECTIVE
  Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment.
  
  
  OBJECTIVE
  To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy.
  
  
  METHODS
  A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012.
  
  
  METHODS
  After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days.
  
  
  METHODS
  The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit.
  
  
  RESULTS
  An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17% (35 of 207) in the nontreatment group and 15% (31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, -8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13% (absolute difference, 0.3%; 95% CI, -5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V.
  
  
  CONCLUSIONS
  Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01015417.
authors.affiliation: Division of Digestive Surgery, Amiens University Medical Center, Amiens, France2Jules Verne University of Picardie, Unit EA4294, Amiens, France3Clinical Research Center, Amiens University Medical Center, Amiens, France.
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Regimbeau
authors.affiliation: Division of Digestive Surgery, Amiens University Medical Center, Amiens, France.
authors.forename: David
authors.initials: D
authors.lastname: Fuks
authors.affiliation: Division of Digestive Disease, Paris Lariboisière Hospital, Paris, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Pautrat
authors.affiliation: Division of Digestive Surgery, Beauvais Hospital, Beauvais, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Mauvais
authors.affiliation: Division of Digestive Surgery, Montreuil-sur-Mer Hospital, Montreuil-sur-Mer, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Haccart
authors.affiliation: Division of Digestive Surgery, Louis Mourier University Hospital, Colombes, France.
authors.forename: Simon
authors.initials: S
authors.lastname: Msika
authors.affiliation: Division of Digestive Surgery, Limoges University Hospital, Limoges.
authors.forename: Muriel
authors.initials: M
authors.lastname: Mathonnet
authors.affiliation: Division of Digestive Surgery, Rouen University Hospital, Rouen, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Scotté
authors.affiliation: Division of Digestive Surgery, Longjumeau Hospital, Longjumeau, France.
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Paquet
authors.affiliation: Division of Digestive Surgery, Jean Verdier University Hospital, Bondy, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Vons
authors.affiliation: Division of Digestive Surgery, Marseille University Hospital La Timone, Marseille, France.
authors.forename: Igor
authors.initials: I
authors.lastname: Sielezneff
authors.affiliation: Division of Digestive Surgery, Montpellier University Hospital, Montpellier, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Millat
authors.affiliation: Division of Digestive Surgery, Caen University Hospital, Caen, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Chiche
authors.affiliation: Division of Anesthesia and Intensive Care, Amiens University Medical Center, Amiens, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Dupont
authors.affiliation: Division of Internal Medicine and Systemic Diseases, Amiens University Medical Center, Amiens, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Duhaut
authors.affiliation: Division of Digestive Surgery, Amiens University Medical Center, Amiens, France.
authors.forename: Cyril
authors.initials: C
authors.lastname: Cossé
authors.affiliation: Division of Clinical Research and Innovation, Amiens University Medical Center, Amiens, France.
authors.forename: Momar
authors.initials: M
authors.lastname: Diouf
authors.affiliation: Division of Digestive Disease, Paris Lariboisière Hospital, Paris, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Pocard
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000517:prevention & control*; D002763:Cholecystectomy; D041881:Cholecystitis, Acute / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D011183:Postoperative Complications / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin