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van CCT (UK)

van CCT (UK)

Short versus standard course postoperative antibiotic treatment for complex acute appendicitis

- candidate number25669
- NTR NumberNTR6128
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-dec-2016
- Secondary IDsNL59492.078.16 MEC-2016-719
- Public TitleShort versus standard course postoperative antibiotic treatment for complex acute appendicitis
- Scientific TitleNon-inferiority multicenter randomized controlled trial comparing short versus standard course postoperative antibiotic treatment for complex acute appendicitis
- ACRONYMAPPIC (Antibiotics following aPPendectomy In Complex appendicitis)
- hypothesisWe hypothesize that discontinuing postoperative antibiotic treatment after 2 days is non-inferior to 5 days of antibiotic treatment.
- Healt Condition(s) or Problem(s) studiedAcute appendicitis
- Inclusion criteria- age minimum 8 years old (no upper limit)
- patients with suspected acute appendicitis, awaiting appendectomy
- written informed consent
- intraoperative diagnosis of a complex appendicitis
- Exclusion criteria- not able to give informed consent
- appendectomy 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-apr-2017
- planned closingdate1-sep-2020
- Target number of participants1066
- InterventionsAfter 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.
- Primary outcomeThe 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.
- Secondary outcomeSecondary objectives are cost-effectiveness, intra-abdominal abscess, superficial and/or deep surgical site infections, mortality, duration of postoperative antibiotic treatment, re-start of antibiotics, hospital stay in hours from the operation, time to reach discharge criteria in hours from the operation, emergency room visits, readmission rate and adverse events on antibiotics (all within 90 days after appendectomy).
- Timepoints90 days (for all outcomes)
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryCurrently 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 and B.P.L. Wijnhoven, both Erasmus MC
- Main changes (audit trail)26-jun-2017 MT
Deleted one exlcusion criterium (patients with a generalized peritonitis), because of amendment METC
- RECORD20-dec-2016 - 26-jun-2017

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