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JAMA. 2014 Jul;312(2):145-54. doi: 10.1001/jama.2014.7586.

Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial.

Author information

  • 1Division 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.
  • 2Division of Digestive Surgery, Amiens University Medical Center, Amiens, France.
  • 3Division of Digestive Disease, Paris Lariboisière Hospital, Paris, France.
  • 4Division of Digestive Surgery, Beauvais Hospital, Beauvais, France.
  • 5Division of Digestive Surgery, Montreuil-sur-Mer Hospital, Montreuil-sur-Mer, France.
  • 6Division of Digestive Surgery, Louis Mourier University Hospital, Colombes, France.
  • 7Division of Digestive Surgery, Limoges University Hospital, Limoges.
  • 8Division of Digestive Surgery, Rouen University Hospital, Rouen, France.
  • 9Division of Digestive Surgery, Longjumeau Hospital, Longjumeau, France.
  • 10Division of Digestive Surgery, Jean Verdier University Hospital, Bondy, France.
  • 11Division of Digestive Surgery, Marseille University Hospital La Timone, Marseille, France.
  • 12Division of Digestive Surgery, Montpellier University Hospital, Montpellier, France.
  • 13Division of Digestive Surgery, Caen University Hospital, Caen, France.
  • 14Division of Anesthesia and Intensive Care, Amiens University Medical Center, Amiens, France.
  • 15Division of Internal Medicine and Systemic Diseases, Amiens University Medical Center, Amiens, France.
  • 16Division of Clinical Research and Innovation, Amiens University Medical Center, Amiens, France.

Abstract

IMPORTANCE:

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.

DESIGN, SETTING, AND PATIENTS:

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.

INTERVENTIONS:

After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days.

MAIN OUTCOMES AND MEASURES:

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 AND RELEVANCE:

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.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01015417.

PMID:
25005651
[PubMed - indexed for MEDLINE]
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