Intraperitoneal administration of fosfomycin, metronidazole and molgramostim versus intravenous conventional antibiotics for perforated appendicitis – a pivotal quasi-randomized controlled trial

Department of Surgery, Herlev Hospital0 个研究点目标入组 12 人开始时间: 2017年11月29日最近更新: 2018年12月4日

试验速览

暂无简介。

•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 at Herlev Hospital and postoperatively at Bispebjerg Hospital)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•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

发起方

Department of Surgery, Herlev Hospital