Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.

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.

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

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