Status:
COMPLETED
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Bayer
Conditions:
Acute Cholecystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most c...
Eligibility Criteria
Inclusion
- Patients of age \> 18 years
- Patients with acute cholecystitis based on three of the following signs
- abdominal pain in the upper right quadrant
- Murphy's sign
- leucocytosis \> 10 /ml
- rectal temperature \> 38 °C or \< 36.5 °C plus
- cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)
- Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)
- Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient
- Informed consent
Exclusion
- ASA IV and V (table 2)
- Septic shock
- Perforation or abscess of the gall bladder
- Impossibility of laparoscopic surgery (further surgery, surgeon, …)
- Additional need of antibiotics due to secondary disease
- Known intolerability of Moxifloxacin
- Known or possible pregnancy, breast feeding
- Life-threatening diseases (life-expectancy \< 48 hours)
- End-stage liver disease (Child-Pugh C)
- Psychiatric or severe neurologic disease
- Relevant bradycardia or other symptomatic arrhythmias
- Significant cardiac disease
- Known long QT-disorders
- Electrolyte disorders, especially hypocalcemia
- Known intolerability of chinolones
- Earlier participation in this trial
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT00447304
Start Date
October 1 2006
End Date
December 1 2010
Last Update
July 23 2012
Active Locations (1)
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1
University Hospital Heidelberg
Heidelberg, Germany, 69120