Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Specific Morbidity Index Scores
研究概览
简要总结
Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed with additional cohort of all elderly patients with acute cholecystitis in the study hospitals during study period.
详细描述
The increasing age is one of the main risk factors for developing complicated gallstone disease. Currently, there is lack of good quality studies comparing risks and benefits of early laparoscopic cholecystectomy in the elderly patients. Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.
Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy vs. conservative) with the least morbidity for elderly patients with acute cholecystitis.
Study design: multicenter randomized controlled trial (RCT) and additional cohort of all elderly patients (>75 years old) with acute cholecystitis.
Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly allocated to either early laparoscopic cholecystectomy or treatment with antibiotics. Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the patients with ASA-class above 4.
Interventions: The study group of patients will undergo early laparoscopic cholecystectomy within 48 hours after hospitalization. The control group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Radiologically confirmed acute cholecystitis
- •Age over 75 yrs
- •American Association of Anesthesiologists Classification class 2-3
- •Duration of symptoms < 5 days
排除标准
- •American Association of Anesthesiologists Classification class 4-5
- •Age under 75 yrs
- •Peritonitis
- •Sepsis or septic shock
- •Duration of symptoms over 6 days
- •Cholestasis or diagnosed stone at common biliary duct.
- •Acute Pancreatitis
结局指标
主要结局
Specific Morbidity Index Scores
时间窗: 1 year postoperatively
The primary outcome is morbidity, all complications will be scored (according to "morbidity-index" -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393)
次要结局
- Pain scores (0-100)(pre-operatively, 1 week, 1 month and 1 year postoperatively)
- Time of hospitalization (days)(1 month)
- Quality of life RAND-36 scores(pre-operatively and 1 year postoperatively)
- Mortality (number of patients)(1 month)
- Number of patients with failure of antibiotic therapy(1 week, 1 month and 1 year postoperatively)
- Number of patients with complications(1 week, 1 month and 1 year postoperatively)
- Cost analysis in euros(1 week, 1 month and 1 year postoperatively)
研究者
Hannu Paajanen
Professor
Kuopio University Hospital