Cholecystitis in Villavicencio Hospitals

NCT06048575 | Completed

• 1 other identifier: GRIVI_2023_04_Cholecystitis
• Study Type: observational
• Target: 609
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Diseases

Keywords

Acute Cholecystitis; Gallbladder Diseases; Cholecystolithiasis; Biliary Tract Surgical Procedures; Laparoscopy; Conversion to Open Surgery; Hospital Surgery Department; Colombia

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  28 days

Secondary Outcomes (7)

• Hospital length of stay

  28 days

• Need of ICU

  28 days

• ICU length of stay

  28 days

• Surgical site infection

  28 days

• Need of mechanical ventilation

  28 days

Study Arms (4)

Number of patients with early therapy

Patients with early surgery (\<72 hours of admission).

Procedure: Cholecystectomy

Number of patients with subacute therapy

Patients with surgery for three days or more.

Procedure: Cholecystectomy

Number of patients with late therapy

Patients with surgery beyond ten days.

Procedure: Cholecystectomy

Number of patients with no therapy

Patients discharged with no surgical therapy.

Procedure: Cholecystectomy

Interventions

Cholecystectomy PROCEDURE

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

Number of patients with early therapy; Number of patients with late therapy; Number of patients with no therapy; Number of patients with subacute therapy

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients admitted with acute or chronic biliary pathology.

You may not qualify if:

• None.

Sponsors & Collaborators

• Hospital Departamental de Villavicencio: lead
• Cooperative University of Colombia: collaborator

Study Sites (1)

Clinica Primavera

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (48)

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• Arroyave Y, Torres F, Sarzosa F, Díaz J, Arroyave Y, Torres F, et al. ¿Es más difícil la colecistectomía laparoscópica después de una colangiopancreatografía retrógrada endoscópica? Experiencia en un hospital de tercer nivel. Rev Colomb Cir. 2020;35(3):436-48.

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• Bustos-Guerrero AM, Guerrero-Macías SI, Manrique-Hernández EF, Gomez-Rincón GA. Severidad de la colecistitis aguda en tiempos de COVID-19: ¿mito o realidad? Rev Colomb Cir. 2022;37(2):206-13.

  RESULT

• Vargas Rodríguez LJ, Agudelo Sanabria MB, Lizcano Contreras RA, Martínez Balaguera YM, Velandia Bustcara EL, Sánchez Hernández SJ, et al. Factores asociados con la conversión de la colecistectomía laparoscópica a colecistectomía abierta. Rev Colomb Gastroenterol. 2017;32(1):20-3.

  RESULT

• Yurgaky-Sarmiento J, Otero-Regino W, Gómez-Zuleta M, Yurgaky-Sarmiento J, Otero-Regino W, Gómez-Zuleta M. Elevación de las aminotransferasas: una nueva herramienta para el diagnóstico de coledocolitiasis. Un estudio de casos y controles. Rev Colomb Gastroenterol. 2020;35(3):319-28.

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  RESULT

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  PMID: 31317760 RESULT

• Janikow C, Corti E, Menso N, Moretti G, Ale M, Sanchez M, Lada PE. Useful of Tokyo guidelines in the diagnosis of acute cholecystitis. Anatomopathologie correlationship. Rev Fac Cien Med Univ Nac Cordoba. 2017;74(2):88-92.

  PMID: 28657526 RESULT

• Ongen G, Nas OF, Aksoy F, Candan S, Dundar HZ, Ozpar R, Inecikli MF, Gursel BE, Tasar P, Savci G. Comparison of severity and complication rates of acute cholecystitis during pandemic and pre-pandemic periods? Acta Radiol. 2023 Apr;64(4):1363-1370. doi: 10.1177/02841851221137048. Epub 2022 Nov 22.

  PMID: 36412110 RESULT

• Lacka M, Obloj P, Spychalski P, Laski D, Rostkowska O, Wieszczy P, Kobiela J. Clinical presentation and outcomes of cholecystectomy for acute cholecystitis in patients with diabetes - A matched pair analysis. A pilot study. Adv Med Sci. 2020 Sep;65(2):409-414. doi: 10.1016/j.advms.2020.08.001. Epub 2020 Aug 18.

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MeSH Terms

Conditions

Biliary Tract Diseases; Cholecystitis, Acute; Gallbladder Diseases; Cholecystolithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Digestive System Diseases; Cholecystitis; Cholelithiasis

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Norton Perez, MD

  Cooperative University of Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 21, 2023
• Study Start: August 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CO (1)