No registrations found.
ID
Source
Brief title
Health condition
Complex acute appendicitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary 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).
Background summary
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)
Study objective
We hypothesize that discontinuing postoperative antibiotic treatment after 2 days is non-inferior to 5 days of antibiotic treatment.
Study design
90 days (for all outcomes)
Intervention
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.
E.M.L. de Wijkerslooth
s Gravendijkwal 230
Rotterdam 3015CE
The Netherlands
+31617616440
e.dewijkerslooth@erasmusmc.nl
E.M.L. de Wijkerslooth
s Gravendijkwal 230
Rotterdam 3015CE
The Netherlands
+31617616440
e.dewijkerslooth@erasmusmc.nl
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 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5946 |
| NTR-old | NTR6128 |
| CCMO | NL59492.078.16 |
| OMON | NL-OMON45262 |