Cholecystitis in Villavicencio Hospitals

Sponsor

Hospital Departamental de Villavicencio (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06048575

Collaborator

Cooperative University of Colombia (Other), Clinica Primavera (Other)

1,500

Enrollment

Locations

17.1

Anticipated Duration (Months)

750

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Diseases	Procedure: Cholecystectomy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Characteristics of the Attention Provided to Patients With Cholecystitis in Villavicencio Hospitals, Colombia: A Retrospective Cross-sectional Trial.

Anticipated Study Start Date :

Jan 28, 2024

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Number of patients with early therapy Patients with early surgery (<72 hours of admission).	Procedure: Cholecystectomy Early or late surgery, ambulatory, emergency, or differed.
Number of patients with subacute therapy Patients with surgery for three days or more.	Procedure: Cholecystectomy Early or late surgery, ambulatory, emergency, or differed.
Number of patients with late therapy Patients with surgery beyond ten days.	Procedure: Cholecystectomy Early or late surgery, ambulatory, emergency, or differed.
Number of patients with no therapy Patients discharged with no surgical therapy.	Procedure: Cholecystectomy Early or late surgery, ambulatory, emergency, or differed.

Outcome Measures

Primary Outcome Measures

Mortality [28 days]
Number of patients deceased due to the biliary disease, complications, or other conditions.

Secondary Outcome Measures

Hospital length of stay [28 days]
Number of days before discharge.
Need of ICU [28 days]
Patients admitted to ICU under any circumstance.
ICU length of stay [28 days]
Number of days hospitalized in ICU
Surgical site infection [28 days]
Number of patients with infections associated with the procedure (superficial, deep, organ/space)
Need of mechanical ventilation [28 days]
Number of patients needing mechanical ventilation
Complicated presentation [28 days]
Number of patients with complications of the disease previous or during hospitalization, but not related to the surgical procedure
Surgical complications [28 days]
Number of patients with complications related to the surgical procedure