The use of perioperative antibiotic prophylaxis in the treatment of acute cholecystitis, a randomized, multicenter, non-inferiority trial

Acute calculous cholecystitis is the third most frequent cause of emergency
admissions to surgical wards. The standard treatment is cholecystectomy. It is
current practice to administer a single prophylactic dose of intravenous
antibiotics, prior the incision.

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. Besides, different studies suggest that extended antibiotic
prophylaxis provides no benefit in preventing postoperative infections in
patients with acute cholecystitis undergoing emergency cholecystectomies.

The remaining quenstion is whether even a single dose of antibiotic
prophylaxis, current practice, is beneficial in case of emergency
cholecystectomy for acute calculous cholecystitis. We hypothesize that omitting
antibiotic prophylaxis in these patiënts does not lead to an increase in
postoperative infection rate

If this study demonstrates that the absence of antibiotic prophylaxis does not
increase the infection rate, the use of perioperative antibiotic for this
indication can be dropped as a whole and the guidelines will be adapted. When
the use of antibiotics appears unnecessary in these patients, the role of
antibiotic prophylaxis in the entire upper gastrointestinal tract surgery
becomes eminent. A decrease of use of antibiotics on such a scale may result in
a large decrease of needless medical activities, costs and bacterial
resistance.

To provide high level of evidence that omitting perioperative antibiotic
prophylaxis does not increase the postoperative infection rate, in patients
with acute calculous cholecystitis undergoing laparoscopic cholecystectomy.

A randomized controlled, multicenter, non-inferiority trial.
Patients will be randomly allocated to:
* No antibiotic treatment
* A single dose of 2000 milligrams of first generation cephalosporin (20mL),
15-30 minutes prior to surgery.

Omitting antibiotic prophylaxis

If this study demonstrates that omitting antibiotic prophylaxis does not
increase the infection rate, it*s use for this indication can be dropped as a
whole and the guidelines will be adapted. Then, the role of antibiotic
prophylaxis in the entire upper gastrointestinal tract surgery becomes eminent.
A decrease of use of antibiotics on such a scale may result in a large decrease
of needless medical activities, costs and bacterial resistance.
If omitting antibiotic prophylaxis should be unjust, an infection that could
have been prevented by antibiotic prophylaxis may occur. A distant infection
requires antibiotic treatment, a surgical site infection may require opening
of the wound or percutaneous drainage of an intra-abdominal abscess. All
procedures in this study are part of the normal medical treatment for acute
cholecystitis, no extra (invasive) procedures or laboratory tests will be
performed. Patient will be seen at the outpatient clinic one week postoperative
and will be called to answer questions, four weeks after surgery.