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

Condition(s) targeted: Acute Cholecystitis

Intervention: moxifloxacin (Drug); cholecystectomy (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Heidelberg

Official(s) and/or principal investigator(s):
Markus W Buechler, Prof., Study Director, Affiliation: University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany
Wolfgang Stremmel, Prof, Study Director, Affiliation: University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany

Overall contact:
Markus W Buechler, Prof., Phone: 6221-566200, Ext: +49, Email: markus.buechler@med.uni-heidelberg.de

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.

Official title: Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-Study

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: morbidity at the test-of-cure visit

Secondary outcome:

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Markus W Buechler, Prof., Phone: 6221-566200, Ext: +49, Email: markus.buechler@med.uni-heidelberg.de

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

Starting date: October 2006
Ending date: March 2007
Last updated: March 13, 2007