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ID
Source
Brief title
Health condition
Acute calculous cholecystitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery
Secondary outcome
The secondary endpoints include all the individual components of the primary endpoint and, in addition, all other complications, the total postoperative duration of hospital stay and the total costs.
Background summary
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.
Study objective
The absence of antibiotic prophylaxis would not lead to an increase of postoperative infectious complications
Study design
Inclusion of patients will take approximately three years. Total duration of follow up is one month.
Intervention
- 2000 milligrams of first generation cephalosporin, 15-30 minutes prior to emergency cholecystectomy
- No antibiotic prophylaxis
P.O. Box 2500
D. Boerma
Nieuwegein 3430 EM
The Netherlands
djamilaboerma@hotmail.com
P.O. Box 2500
D. Boerma
Nieuwegein 3430 EM
The Netherlands
djamilaboerma@hotmail.com
Inclusion criteria
- Mild or moderate acute calculous cholecystitis
- Cholecystectomy
- Written informed consent
Exclusion criteria
- < 18 years of age
- Acalculous cholecystitis
- Severe acute calculous cholecystitis
- Already receiving antibiotics prior to inclusion
- Proven allergy to cefazoline
- Pregnancy
- Indication for ERCP on admission
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5667 |
| NTR-old | NTR5802 |
| CCMO | NL53084.100.15 |
| OMON | NL-OMON43999 |