The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial
Condition: Acute Cholecystitits
MeSH terms: Cholecystitis; Acalculous Cholecystitis
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Antibiotic treatment; No antibiotics
Intervention type(s): Drug; Drug
Intervention description(s): Cefuroxime 750mg X3/d, Ampicillin 2G X4/d, Flagyl 500mg X3/d, Augmentin 1G X3/d, Gentamycin 240mg X1/d, Clindamycin 600mg X3/d, Ciprofloxacin 400mg X2/d All drugs will be administered IV until clinical improvement.; Allowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted through the emergency department that are diagnosed with acute
        cholecystits and meet the inclusion criteria will be given the opportunity to participate
        in the trial. Informed consent is required. Patients may withdraw from the study at any
        time without giving reasons and without jeopardizing further treatment.