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

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00447304

Collaborator

Bayer (Industry)

644

Enrollment

Location

Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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