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OpenTrials
Completed

NCT Number: NCT06048575

Cholecystitis in Villavicencio Hospitals

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.

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Key information

Conditions

Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

16 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Primavera

Villavicencio, Meta Department, 50001, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted with acute or chronic biliary pathology.

Exclusion criteria

  • None.

Treatment and study plan

Cholecystectomy

Procedure

Early or late surgery, ambulatory, emergency, or differed.

Primary outcomes

  1. Mortality

    Time frame: 28 days

    Number of patients deceased due to the biliary disease, complications, or other conditions.

Secondary outcomes

  1. Hospital length of stay

    Time frame: 28 days

    Number of days before discharge.

  2. Need of ICU

    Time frame: 28 days

    Patients admitted to ICU under any circumstance.

  3. ICU length of stay

    Time frame: 28 days

    Number of days hospitalized in ICU

  4. Surgical site infection

    Time frame: 28 days

    Number of patients with infections associated with the procedure (superficial, deep, organ/space)

  5. Need of mechanical ventilation

    Time frame: 28 days

    Number of patients needing mechanical ventilation

  6. Complicated presentation

    Time frame: 28 days

    Number of patients with complications of the disease previous or during hospitalization, but not related to the surgical procedure

  7. Surgical complications

    Time frame: 28 days

    Number of patients with complications related to the surgical procedure

Sponsors and collaborators

Lead sponsor

Hospital Departamental de Villavicencio

Other

Collaborators

  • Cooperative University of Colombia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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