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Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy (ACDC)
This study is currently recruiting participants.
Study NCT00447304   Information provided by University of Heidelberg
First Received: March 13, 2007   No Changes Posted

March 13, 2007
March 13, 2007
October 2006
 
morbidity at the test-of-cure visit
Same as current
No Changes Posted
  • Morbidity over 75 days using the score system showed in table 1
  • Morbidity 3 days after cholecystectomy (early or elective)
  • Necessity rate of conversion from laparoscopic to open surgery
  • Change of antibiotic due to non-response or non-toleration of moxifloxacin
  • Mortality at day 75
  • Cost-efficiency (comparing both trial branches)
  • Hospital time
  • Safety and tolerability of Moxifloxacin
  • In-hospital time after cholecystectomy (days)
Same as current
 
Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-Study

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 cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. This study is performed to evaluate if one therapy is superior.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Acute Cholecystitis
  • Drug: moxifloxacin
  • Procedure: cholecystectomy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
644
March 2007
 

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact: Markus W Buechler, Prof. 6221-566200 ext +49 markus.buechler@med.uni-heidelberg.de
Contact: Jens Encke, Prof. 06221-568825 ext +49 jens.encke@med.uni-heidelberg.de
Germany
 
NCT00447304
 
2006-002056-14, AC-DC-01/Version 02/6.04.06
University of Heidelberg
Bayer
Study Director: Markus W Buechler, Prof. University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany
Study Director: Wolfgang Stremmel, Prof University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
University of Heidelberg
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP