|- candidate number||10396|
|- NTR Number||NTR3089|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-sep-2011|
|- Secondary IDs|| VCMO Antonius Hospital Nieuwegein|
|- Public Title||Perioperative antibiotic use in the treatment of acute inflammation of the gallbladder. |
|- Scientific Title||Perioperative antibiotic use in the treatment of acute calculous cholecystitis.|
|- hypothesis||Extended postoperative antibiotic prophylaxis will not reduce the infectious complication rate after laparoscopic cholecystectomy in acute cholecystitis.|
|- Healt Condition(s) or Problem(s) studied||Acute calculous cholecystitis|
|- Inclusion criteria||1. Acute calculous cholecystitis;|
2. APACHE-II score 1-6;
3. Written informed consent.
|- Exclusion criteria||1. < 18 years of age;|
2. APACHE-II score ≥ 7;
3. Already receiving antibiotics prior to diagnosis;
4. Proven allergy to Cefuroxime/ Metronidazole;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jan-2014|
|- Target number of participants||158|
|- Interventions||1. Extended postoperative antibiotic prophylaxis (cefuroxime 750 mgs 3dd & metronidazole 500mgs 3dd during 72 hours);|
2. Postoperative clinical observation.
|- Primary outcome||All infectious complications.|
|- Secondary outcome||1. Individual components of composite endpoint;|
2. All other complications;
3. Total length of hospital stay;
4. Total direct and indirect costs.
|- Timepoints||Inclusion of patients will take approximately two years. Total duration of follow up is one month.|
An interim analysis will be performed every six months.
|- Trial web site||www.cholecystitis.nl|
|- CONTACT FOR PUBLIC QUERIES||MD. D. Boerma|
|- CONTACT for SCIENTIFIC QUERIES||MD. D. Boerma|
|- Sponsor/Initiator ||Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|St Antonius Hospital, Nieuwegein|
|- Brief 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 administration.
The PEANUTS trial is initiated to demonstrate that extended postoperative antibiotic therapy does not decrease the infectious complication rate in laparoscopic cholecystectomy for acute cholecystitis. It is designed as a multi centre randomized controlled trial, including low risk patients with acute calculous cholecystitis. Patients will be randomised to receive either extended postoperative antibiotic prophylaxis or clinical observation after laparoscopic cholecystectomy. The endpoint is a composed endpoint of all infectious complications.
|- Main changes (audit trail)|
|- RECORD||29-sep-2011 - 11-aug-2012|