Status:
COMPLETED
Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Bispebjerg Hospital
Conditions:
Appendicitis Perforated
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this trial is to evaluate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CS...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual laparoscopic appendectomy
- Perforated appendicitis (diagnosed during surgery by the surgeon)
- Negative p-HCG (women)
- Written informed consent after written and verbal information (preoperatively for the intervention group and postoperatively for the control group)
Exclusion
- Cannot understand, read or speak Danish
- Previous allergic reaction to fosfomycin, metronidazole, rhGM-CSF, or penicillins e.g. piperacillin or amoxicillin
- Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy or appendicitis without perforation
- Other intra-abdominal pathology requiring surgical intervention at the same operation
- Known renal or hepatic disease or biochemical evidence at the time of admission
- Known hematologic disease in current medical treatment
- American Society of Anesthesiologists (ASA) physical status ≥4 (a patient with severe systemic disease that is a constant threat to life)
- Body weight \>110 kg
- Surgery converted to open appendectomy
- Anticipated compliance problems
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03435900
Start Date
February 14 2018
End Date
July 17 2018
Last Update
October 16 2018
Active Locations (2)
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1
Department of Surgery, Bispebjerg Hospital
Copenhagen, Denmark, 2400
2
Department of Surgery, Herlev Hospital
Herlev, Denmark, 2730