Clinical trial NCT06048575: Cholecystitis in Villavicencio Hospitals
Official title: Characteristics of the Attention Provided to Patients With Cholecystitis in Villavicencio Hospitals, Colombia: A Retrospective Cross-sectional Trial.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Biliary Tract Diseases
Keywords: Acute Cholecystitis
Gallbladder Diseases
Cholecystolithiasis
Biliary Tract Surgical Procedures
Laparoscopy
Conversion to Open Surgery
Hospital Surgery Department
Colombia
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
Collaborators: name: Cooperative University of Colombia
name: Clinica Primavera
First posted: 2023-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The trial participants are those admitted requesting emergency, hospital, ambulatory, or ICU attention for biliary pathology during the study period, according to the admission registers.

Brief summary: Background: Acute cholecystitis is a frequent cause of visits to the emergency ward. The complications of delays in attention and surgical therapy are substantial and should be considered to prevent them timely.

Objective: The study aims to evaluate the assistance provided to patients for cholecystitis in Villavicencio hospitals.

Methodology: A retrospective cross-sectional trial will be performed. The source of information will be the surgical database of hospitals at Villavicencio from 2019 to 2022. The records selected will be exported to an Excel spreadsheet for debugging and analysis. The central distribution and dispersion of numerical variables will be analyzed, as frequency and proportion of categorical variables with the software Prism 10.01.1 for Mac iOS. Chi-square and U-Mann \& Whitney tests will compare variables according to the data type. A p\<0.05 will be defined as statistically significant.

Expected results: the researchers hope to define the frequency of hospital discharges due to acute cholecystitis, the type of procedure performed, complications, and outcomes.

Conclusions: The research is feasible because the necessary information is available for evaluation, and it is helpful for the institutions and the region.

Detailed description: Biliary diseases are some leading causes of admission to emergency wards. Cholelithiasis and acute cholecystitis are prevalent in the Orinoquia region. Young and female populations are predominantly affected. Complications are prone to delayed definitive surgical therapy, which increases costs and the use of resources. Guidelines recommend early surgery during hospitalization for the first episode to minimize difficulties. There are limitations in the available technology recommended for treatment, especially in institutions dedicated to vulnerable populations. Laparoscopic cholecystectomy is the primary goal in cases required for gall bladder removal. Although the technology and trained personnel are available in local institutions, open procedures are still performed primarily, and restrictions are due to insurance coverage after more than 30 years of disseminating laparoscopic cholecystectomy worldwide.

It is necessary to know the prevalence of the disease and the therapy provided in general hospitals from the region to analyze associated factors with undesired results.

Determining the characteristics of patients admitted to hospitals by biliary pathology will provide essential information on the severity, care provided, definitive treatment, opportunity, and outcomes. Such an analysis will give knowledge to prioritize policies and resources, upgrade clinical practice guidelines, and improve early and long-term results.

Eligibility criteria: Inclusion Criteria:

* Patients admitted with acute or chronic biliary pathology.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 28 days
measure: Need of ICU
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: Surgical site infection
timeFrame: 28 days
measure: Need of mechanical ventilation
timeFrame: 28 days
measure: Complicated presentation
timeFrame: 28 days
measure: Surgical complications
timeFrame: 28 days
Other outcomes:
Locations:
city: Villavicencio
country: Colombia
facility: Clinica Primavera
state: Meta
city: Villavicencio
country: Colombia
facility: Hospital Departamental de Villavicencio
state: Meta
Study officials:
affiliation: Cooperative University of Colombia
name: Norton Perez, MD
role: PRINCIPAL_INVESTIGATOR
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