Acute Cholecystitis
Conditions
Keywords
acute cholecystitis, cholecystectomy, antibiotic treatment, moxifloxacin, intraabdominal infection, morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy
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.
Interventions
DRUGmoxifloxacin
PROCEDUREcholecystectomy
Sponsors
Bayer
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| morbidity at the test-of-cure visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Morbidity over 75 days using the score system showed in table 1 | — |
| Hospital time | — |
| Safety and tolerability of Moxifloxacin | — |
| In-hospital time after cholecystectomy (days) | — |
| Cost-efficiency (comparing both trial branches) | — |
Countries
Germany
Outcome results
None listed