Cholecystitis in Villavicencio Hospitals

Recruiting

• Conditions: Biliary Tract Diseases

• Registration Number: NCT06048575
• Lead Sponsor: Hospital Departamental de Villavicencio

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.

Study Timeline

• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-16
• Study First Posted: 2023-09-21
• Study Start: 2025-08-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients admitted with acute or chronic biliary pathology.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	28 days	Number of patients deceased due to the biliary disease, complications, or other conditions.

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (2)

Clinica Primavera; 🇨🇴 Villavicencio, Meta Department, Colombia

Hospital Departamental de Villavicencio; 🇨🇴 Villavicencio, Meta Department, Colombia