ACDCAcute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
Data Collection
Biliary Tract Diseases+4
+ Cholecystitis
+ Digestive System Diseases
Treatment Study
Summary
Study start date: October 1, 2006
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.644 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location