Brief Title
Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.
Official Title
Evaluation of the Applicability and Effectiveness of a Protocol for the Multidisciplinary Management of Acute Cholecystitis
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.
Study Type
Observational
Primary Outcome
Inclusion rate
Secondary Outcome
Protocol compliance failure
Condition
Acute Cholecystitis
Study Arms / Comparison Groups
Patients unfit for Surgery with mild-moderate acute cholecyst
Description: Conservative treatment (antibiotics, etc). EUS-guided gallbladder drainage will be considered in recurrent acute cholecystitis and in patients with no improvement in 48-72h after admission.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
600
Start Date
July 1, 2020
Completion Date
January 2023
Primary Completion Date
July 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Federico Bolado Concejo, MD, PhD, 0034848422025, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04543578
Organization ID
DIGESTIVO CHN-VBP
Responsible Party
Sponsor
Study Sponsor
Fundacion Miguel Servet
Study Sponsor
Federico Bolado Concejo, MD, PhD, Principal Investigator, Complejo Hospitalario de Navarra
Verification Date
December 2020