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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447304
First Posted: March 14, 2007
Last Update Posted: July 23, 2012
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.
Collaborator:
Bayer
Information provided by:
Heidelberg University
  Purpose
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 Intervention Phase
Acute Cholecystitis Drug: moxifloxacin Procedure: cholecystectomy Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 644
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00447304


Locations
Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Bayer
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00447304     History of Changes
Other Study ID Numbers: 2006-002056-14
AC-DC-01/Version 02/6.04.06
First Submitted: March 13, 2007
First Posted: March 14, 2007
Last Update Posted: July 23, 2012
Last Verified: March 2007

Keywords provided by Heidelberg University:
acute cholecystitis
cholecystectomy
antibiotic treatment
moxifloxacin
intraabdominal infection
morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Moxifloxacin
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs