Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 644
- 试验地点
- 2
- 主要终点
- morbidity at the test-of-cure visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
morbidity at the test-of-cure visit
次要结局
- 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)