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Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy (ACDC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447304
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : July 23, 2012
Information provided by:
Heidelberg University

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 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.

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Drug: moxifloxacin Procedure: cholecystectomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
Study Start Date : October 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Primary Outcome Measures :
  1. morbidity at the test-of-cure visit

Secondary Outcome Measures :
  1. Morbidity over 75 days using the score system showed in table 1
  2. Morbidity 3 days after cholecystectomy (early or elective)
  3. Necessity rate of conversion from laparoscopic to open surgery
  4. Change of antibiotic due to non-response or non-toleration of moxifloxacin
  5. Mortality at day 75
  6. Cost-efficiency (comparing both trial branches)
  7. Hospital time
  8. Safety and tolerability of Moxifloxacin
  9. In-hospital time after cholecystectomy (days)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447304

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University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00447304    
Other Study ID Numbers: 2006-002056-14
AC-DC-01/Version 02/6.04.06
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: March 2007
Keywords provided by Heidelberg University:
acute cholecystitis
antibiotic treatment
intraabdominal infection
morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy
Additional relevant MeSH terms:
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Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents