Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy - Full Text View

Sponsors and Collaborators:	University of Heidelberg Bayer
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00447304

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 III

MedlinePlus related topics: Antibiotics

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-Study

Further study details as provided by University of Heidelberg:

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
Estimated Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447304

Contacts

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

Locations

Germany
University Hospital Heidelberg	Recruiting
Heidelberg, Germany, 69120
Contact: Jens Encke, Prof 6221-568825 ext +49 jens.encke@med.uni-heidelberg.de
Contact: Carsten Gutt, Prof. 6221-5636334 ext +49 carsten.gutt@med.uni-heidelberg.de
Principal Investigator: Jens Encke, Prof.
Principal Investigator: Carsten Gutt, Prof.
Sub-Investigator: Joerg Koeninger, PD Dr.
Sub-Investigator: Kilian Weigand, Dr.

Sponsors and Collaborators

University of Heidelberg

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

Study ID Numbers:	2006-002056-14, AC-DC-01/Version 02/6.04.06
Study First Received:	March 13, 2007
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00447304
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

acute cholecystitis
cholecystectomy
antibiotic treatment

moxifloxacin
intraabdominal infection
morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy

Study placed in the following topic categories:

Gallbladder Diseases
Digestive System Diseases
Moxifloxacin
Cholecystitis, Acute

Acalculous Cholecystitis
Biliary Tract Diseases
Cholecystitis

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009