The safety and pharmacokinetics of intraperitoneal administration of granulocyte-macrophage colony-stimulating factor, fosfomycin, and metronidazole in patients undergoing appendectomy for uncomplicated appendicitis

Department of Surgery, Herlev Hospital0 个研究点目标入组 14 人开始时间: 2016年2月19日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•Men =18 years old
•Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual appendectomy
•Written informed consent after written and verbal information
•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 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Cannot understand, read or speak Danish
•Previous allergic reaction to fosfomycin, metronidazole, or GM-CSF
•Perforated appendicitis (diagnosed either during surgery or at a preoperative computer tomography (CT) scan)
•Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy
•Other intra-abdominal pathology requiring surgical intervention (diagnosed either during surgery or at a preoperative CT-scan)
•Known renal or hepatic disease or biochemical evidence at the time of admission
•Known autoimmune disease or other chronic inflammation
•Known hematologic disease or cancer
•Previous abdominal surgery (either laparoscopic or open surgery)
•Daily use or use of medication one week prior to or during the trial period apart from painkillers such as paracetamol, ibuprofen, tramadol, and morphine as well as drugs needed for anaesthesia, thrombosis prophylaxis, and nausea. Limitations for antibiotics are defined below
•Use of other antimicrobial agents than the trial treatment one month before until 24 hours after the trial treatment
•Participant in another drug trial one month prior to the date of the surgery
•Body mass index =35 kg/m2
•Weekly intake of alcohol >14 units, where one unit corresponds to 12 g alcohol

发起方

Department of Surgery, Herlev Hospital