Evaluation of the Applicability and Effectiveness of a Protocol for the Multidisciplinary Management of Acute Cholecystitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Inclusion rate
研究概览
简要总结
Acute cholecystitis is a complex disease and its management is sometimes controversial. Two main factors contribute to its complexity: the patient's surgical risk and the possibility of concomitant choledocholithiasis. The design of a multidisciplinary protocol between the services of Gastroenterology and Surgery aims to harmonize its management and to adapt it to the most recent guidelines. As it concerns more than one department, it is crucial to analyze its compliance and effectiveness.
详细描述
Adult patients attending the emergency department and diagnosed with acute cholecystitis will be asked to participate. Those considered not suitable for surgery will be admitted in a medical department and assigned to conservative treatment or cholecystostomy, according to their acute cholecystitis severity. In patients suitable for surgery, risk of concomitant choledocholithiasis will be assessed and patients will be assigned to low risk or intermediate-high risk. The latter will be admitted in a medical department, and choledocholithiasis will be ruled out and treated if present. The former will be offered cholecystectomy or cholecystostomy according to their surgical risk and acute cholecystitis severity. A flowchart with extended information is attached.
PRIMARY OBJECTIVES
• To harmonize the management of acute cholecystitis with a multidisciplinary protocol based on the most recent guidelines.
SECONDARY OBJECTIVES
- To analyze the compliance with this protocol.
- To evaluate the validity of the criteria used in the decision-making process.
- To assess the morbidity and mortality of different groups of patients according to the selected treatment, severity of cholecystitis and baseline characteristics of the patient.
- To estimate the resource use in each group of patients.
- To compare current data with a previous period.
- To adapt and modify the protocol according the study results. INCLUSION CRITERIA
- Patients aged 18 or older who agree to participate (an informed consent signature is required)
- Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 aged 18 or older who agree to participate (an informed consent signature is required)
- •Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
排除标准
- •Patients under 18 years or patients who refuse to participate in the study
- •Patients diagnosed with acute cholangitis during admission for other causes.
结局指标
主要结局
Inclusion rate
时间窗: During inclusion period
Rate of patients with AC diagnosis registered in the study
Mortality in the different subtypes of patients
时间窗: three months after hospital discharge
90-day disease-specific mortality
Morbidity in the different subtypes of patients
时间窗: three months after hospital discharge
length of hospital stay, need for unplanned readmissions, recurrent cholecystitis
Protocol compliance
时间窗: During inclusion period
Rate of patients with complete protocol compliance
次要结局
- Evaluate the technical success(During inclusion period (up to 1 year))
- Protocol compliance failure(every 3 months throughout study completion (up to 1 year))
- Evaluate the accuracy in the diagnosis(three months after hospital discharge or after ERCP)