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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Cholecystitis

Intervention / Treatment
-----------------
* Drug: moxifloxacin
* Procedure: cholecystectomy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: moxifloxacin|nan|
|Procedure: cholecystectomy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity at the test-of-cure visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute cholecystitis, cholecystectomy, antibiotic treatment, moxifloxacin, intraabdominal infection, morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy