We hypothesize that discontinuing postoperative antibiotic treatment after 2 days is non-inferior to 5 days of antibiotic treatment.
ID
Bron
Verkorte titel
Aandoening
Complex acute appendicitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is a composite endpoint postoperative infectious complications related to appendectomy, including intra-abdominal abscess and surgical site infection, and mortality within 90 days after appendectomy.
Achtergrond van het onderzoek
Currently there is no consensus on the adequate duration of postoperative antibiotic treatment following appendectomy in complex appendicitis, due to a lack of medical evidence. Furthermore antibiotic resistance is a growing global health issue. The present study will investigate whether a short course (2 days) is as safe and effective as standard practice (5 days). The hypothesis is that short course is non-inferior to standard course. If this is proven, potential benefits of this study are less use of antibiotics, less overtreatment and resistance, as well as possibly shorter length of stay and lower hospital costs for this patient group.
Principal Investigators: A.L. van den Boom (Erasmus MC; UMC Groningen) and B.P.L. Wijnhoven (Erasmus MC)
Doel van het onderzoek
We hypothesize that discontinuing postoperative antibiotic treatment after 2 days is non-inferior to 5 days of antibiotic treatment.
Onderzoeksopzet
90 days (for all outcomes)
Onderzoeksproduct en/of interventie
After appendectomy for complex acute appendicitis, patients will be randomized to either A) discontinuing antibiotic treatment after 48 hours of intravenous antibiotics (intervention group), or B) continuing antibiotic treatment for three more days (control group). Antibiotics given intravenously are cefuroxime and metronidazole. In children the doses will be adjusted according to their weight.
Publiek
E.M.L. de Wijkerslooth
s Gravendijkwal 230
Rotterdam 3015CE
The Netherlands
+31617616440
e.dewijkerslooth@erasmusmc.nl
Wetenschappelijk
E.M.L. de Wijkerslooth
s Gravendijkwal 230
Rotterdam 3015CE
The Netherlands
+31617616440
e.dewijkerslooth@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- age minimum 8 years old (no upper limit)
- patients with suspected acute appendicitis, awaiting appendectomy
- written informed consent
- intraoperative diagnosis of a complex appendicitis
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- not able to give informed consent
- appendectomy à froid
- severe sepsis, defined as sepsis-induced tissue hypoperfusion or organ dysfunction
- conservative treatment of acute appendicitis
- ASA score IV or not able to undergo surgery
- known allergy or any other contraindication for the use of the study medication
- immunocompromised patients
- pregnancy
- use of other antibiotics
- intraoperative diagnosis of a simple appendicitis
- intraoperative appendicular infiltration not amendable for appendectomy
- inadequate source control in the opinion of the surgeon
Opzet
Deelname
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| Register | ID |
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