Acute Cholecystitis
Conditions
Keywords
Acute cholecystitis, EUS-guided cholecystostomy, Percutaneous cholecystostomy, Laparoscopic cholecystectomy
Brief summary
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.
Detailed description
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. EXCLUSION CRITERIA * Patients under 18 years or patients who refuse to participate in the study * Patients diagnosed with acute cholangitis during admission for other causes.
Interventions
None listed
Sponsors
Fundacion Miguel Servet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
* Patients under 18 years or patients who refuse to participate in the study * Patients diagnosed with acute cholangitis during admission for other causes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inclusion rate | During inclusion period | Rate of patients with AC diagnosis registered in the study |
| Protocol compliance | During inclusion period | Rate of patients with complete protocol compliance |
| Morbidity in the different subtypes of patients | three months after hospital discharge | length of hospital stay, need for unplanned readmissions, recurrent cholecystitis |
| Mortality in the different subtypes of patients | three months after hospital discharge | 90-day disease-specific mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol compliance failure | every 3 months throughout study completion (up to 1 year) | Identify causes of protocol compliance failure |
| Evaluate the technical success | During inclusion period (up to 1 year) | Evaluate clinical success and adverse events of the different treatments. |
| Evaluate the accuracy in the diagnosis | three months after hospital discharge or after ERCP | Evaluate the accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) and EUS in the diagnosis of concomitant choledocholithiasis |
Countries
Spain
Contacts
Primary ContactFederico Bolado Concejo, MD, PhD
Backup ContactRuth Garcia Rey, MS
Outcome results
None listed