To demonstrate that extended postoperative antibiotic treatment does not decrease the infectious complication rate in laparoscopic cholecystectomy for acute cholecystitis.
ID
Source
Brief title
Condition
- Gallbladder disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite endpoint consisting of all infectious complications:
- Wound infection
- Intra-abdominal infection
- Pneumonia
- Urinary tract infection
Secondary outcome
- All individual components of the composite endpoint
- Other complications
- Need for re-intervention
- Need for re-admission
- Total duration of admission
- Total direct and indirect costs
Background summary
In the treatment of acute cholecystitis the use of antibiotics is disputable.
It is current practice to administer a single prophylactic dose of intravenous
antibiotics 15-30 minutes prior to the first incision. Whether postoperative
prolongation of antibiotic treatment has any additional value in preventing
infectious complications remains unclear but many surgeons still advise to do
so. Since the agents are preferably administered through the intravenous route,
hospital admission is lengthened and therefore costs are higher. In addition
bacterial resistance can occur making future treatment more difficult.
Current literature and our own retrospective case series does not provide the
surgical community with the much needed answer to the question whether
prolonged postoperative antibiotic prophylaxis does decrease the infectious
complication rate in low risk patients with acute cholecystitis.
Although selection bias is most certainly present in the available studies,
results do not show any beneficial effect of prolonged antibiotic treatment.
Study objective
To demonstrate that extended postoperative antibiotic treatment does not
decrease the infectious complication rate in laparoscopic cholecystectomy for
acute cholecystitis.
Study design
Multi center randomized controlled open trial
Intervention
Extended postoperative antibiotic prophylaxis (cefuroxime 750mgs 3dd/
metronidazole 500mgs 3dd) intravenously during 72 hours
Study burden and risks
There are na additional risks associated with participation in this trial. Both
intervention methods (extended postoperative antibiotic prophylaxis and
clinical observation) are used widely in the current surgical community. The
risks of participation are therefore no greater or different from those
associated with treatment according to the local hospital protocol.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
* Acute calculous cholecystitis, defined according to Tokyo Guidelines
* Laparoscopic cholecystectomy
* APACHE-II score 1-6
Exclusion criteria
* < 18 years of age
* APACHE-II score >= 7
* Already receiving antibiotics at time of/prior to diagnosis
* Proven allergy to cefuroxime/ metronidazole
* Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004878-29-NL |
| CCMO | NL38015.100.11 |