Acute Cholecystitits Clinical Trial
Official title:
The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial
The treatment of acute cholecystitis includes limited oral intake, antibiotics and early or
delayed surgery. To date there are no randomized trials proving the benefit of antibiotic
treatment.
The aim of this study is to prospectively and randomly compare between patients that are
admitted for acute cholecystitis and treated with or without antibiotics.
Cholelithiasis and inflammatory biliary tract disease constitute a major health problem in
western countries. Acute cholecystitis is the third major cause of emergency admission to a
surgical ward and its incidence increases with increasing age. Acute cholecystitis is
defined as acute inflammation of the gallbladder which is commonly caused by gallstones
which are impacted in the cystic duct. The treatment of acute cholecystitis varies between
different medical centers around the world. In some hospitals, mainly in the US, the most
common treatment is early laparoscopic cholecystectomy within 72 hours from the onset of
symptoms / admission. However, in the UK and many other centers in Europe the treatment of
acute cholecystitis is conservative (NPO, IV fluids and antibiotics) and laparoscopic
cholecystectomy is delayed. The reasons for delayed surgery differ between institutions and
include the assumption of decreased complications, surgeon and OR availability and schedule,
costs, and hospital policy.
A recent metanalysis proved similar safety and efficacy of early and delayed laparoscopic
cholecystectomy. The conversion rate, length of operation and complication rate (overall
complication rate, intra-abdominal collection, bile leak, and CBD injury) were also
comparable.
At Hadassah-Hebrew University Medical Center, Mount Scopus patients with acute cholecystitis
are treated conservatively followed by delayed laparoscopic cholecystectomy. Over the years
this approach proved to carry relatively low rate of complications, mainly bile duct
injuries <1%, without interruption to the busy OR schedule.
Regardless to the lack of evidence based guidelines for the treatment of acute cholecystitis
the traditional triad of NPO, IV fluids and antibiotics was adopted at our institution
vis-à-vis the higher complication and conversion rate for early cholecystectomy. The
antibiotic treatment is associated with side effects, costs and most important unavoidable
development of bacterial drug resistance. However, to date there are no randomized trials
proving the superiority of either one of these methods.
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Observational Model: Case Control, Time Perspective: Prospective