Perioperative antibiotic use in the treatment of acute inflammation of the gallbladder.

Rationale

It is current practice to administer a single prophylactic dose of intravenous antibiotics, 15-30 minutes prior the incision, in patients who undergo an emergency cholecystectomy. In current literature, high level evidence is available that in patients undergoing elective cholecystectomy for uncomplicated cholelithiasis, prophylactic antibiotics do not decrease the incidence of postoperative infections. Recent studies, as well as our own data, show that extended treatment with antibiotic prophylaxis doesn’t benefit the outcome in terms of surgical site infections and does increase duration of hospital stay and costs. Furthermore the use of unnecessary antibiotics leads to an increased resistance to antibiotics. The remaining question is whether even a single dose antibiotic prophylaxis is beneficial in patient with acute cholecystitis who undergo laparoscopic cholecystectomy.



Objective

This study is designed to demonstrate whether or not patients who undergo cholecystectomy for acute calculous cholecystitis, benefit from preoperative antibiotic prophylaxis



Study design

A randomized controlled, multicenter, open-label non-inferiority trial



Study population

All patients with acute calculous cholecystitis undergoing emergency cholecystectomy over 18 years of age.



Intervention

A. No antibiotic treatment

B. A single dose of 2000 mg of cefazolin, 15-30 minutes prior to surgery

Main study parameters/endpoints

The primary outcome measure is the development of postoperative infections (surgical site and distant infections) within 30 days after surgery. Secondary endpoints are the individual infections, other postoperative complications, duration of hospital stay and total costs.

The absence of antibiotic prophylaxis would not lead to an increase of postoperative infectious complications

Inclusion of patients will take approximately three years. Total duration of follow up is one month.

- 2000 milligrams of first generation cephalosporin, 15-30 minutes prior to emergency cholecystectomy

- No antibiotic prophylaxis