Acute cholecystitis – early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study

A multicenter, prospective, randomized non-blinded study to compare treatment outcome, complications and 75-day morbidity in patients with acute cholecystitis randomized to laparoscopic cholecystectomy within 24 hours of symptom onset or antibiotic treatment with moxifloxacin and subsequent elective cholecystectomy. For consistency in both arms moxifloxacin, a fluorquinolone with broad spectrum of activity and high bile concentration is used as antibiotic. Duration: October 2006 – November 2008The trial was planned and is being conducted and analysed by the Departments of Gastroenterology and General Surgery at the University Hospital of Heidelberg according to the ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and the Good Clinical Practice guideline (GCP).ClinicalTrials.gov NCT00447304Acute cholecystitis is one of the most significant acute diseases in the Western World, and may be associated with only mild pain and nausea or become a severe, life-threatening illness due to complications. Acute cholecystitis is mainly caused by gall stones, whilst cholestasis is mainly associated with superinfection with bacteria, in general species of enterobacteria, enterococci, bacteroides and anaerobic streptococci [1].The principal complication is recurrent biliary colic and cholestasis. The latter may lead to ascending cholangitis, and whilst this can be managed with antibiotics, other complications can not be cured conservatively, such as gangrenous changes, gall bladder perforation and biliary leakage, and acute necrotic gallstone pancreatitis [2-5]. Liver abscesses and underlying incidental carcinoma have also been reported in some cases [2,6].The risk of developing second and subsequent episodes of acute cholecystitis is higher than the risk of suffering an initial episode [7,8]. Laparoscopic cholecystectomy is therefore usually recommended, but whether this should be performed immediately or aft