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


- candidate number24421
- NTR NumberNTR5802
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2016
- Secondary IDsNL53084.100.15 MEC-U St. Antonius Hospital Nieuwegein
- Public TitlePerioperative antibiotic use in the treatment of acute inflammation of the gallbladder.
- Scientific TitleThe use of perioperative antibiotic prophylaxis in the treatment of acute cholecystitis
- ACRONYMPEANUTS II
- hypothesisThe absence of antibiotic prophylaxis would not lead to an increase of postoperative infectious complications
- Healt Condition(s) or Problem(s) studiedCholecystitis
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2019
- Target number of participants454
- Interventions- 2000 milligrams of first generation cephalosporin, 15-30 minutes prior to emergency cholecystectomy
- No antibiotic prophylaxis
- Primary outcomeThe primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery
- Secondary outcomeThe 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.
- TimepointsInclusion of patients will take approximately three years. Total duration of follow up is one month.
- Trial web sitewww.cholecystitis.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. D. Boerma
- CONTACT for SCIENTIFIC QUERIESMD. D. Boerma
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- PublicationsNA
- Brief summaryRationale
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 doesnt 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.
- Main changes (audit trail)
- RECORD31-mei-2016 - 4-jun-2016


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