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

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ClinicalTrials.gov Identifier: NCT00447304

Recruitment Status : Completed

First Posted : March 14, 2007

Last Update Posted : July 23, 2012

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bayer

Information provided by:

Heidelberg University

Tracking Information

First Submitted Date ^ICMJE

March 13, 2007

First Posted Date ^ICMJE

March 14, 2007

Last Update Posted Date

July 23, 2012

Study Start Date ^ICMJE

October 2006

Actual Primary Completion Date

November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

morbidity at the test-of-cure visit

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Cholecystitis

Intervention ^ICMJE

Drug: moxifloxacin
Procedure: cholecystectomy

Study Arms ^ICMJE

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

644

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

December 2010

Actual Primary Completion Date

November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00447304

Other Study ID Numbers ^ICMJE

2006-002056-14
AC-DC-01/Version 02/6.04.06

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Heidelberg University

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Bayer

Investigators ^ICMJE

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

PRS Account

Heidelberg University

Verification Date

March 2007

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

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