The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cholecystitis in Villavicencio Hospitals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06048575
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : December 12, 2023
Sponsor:
Collaborators:
Cooperative University of Colombia
Clinica Primavera
Information provided by (Responsible Party):
Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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.
Estimated Study Start Date : January 28, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
    Number of patients deceased due to the biliary disease, complications, or other conditions.


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Patients admitted with acute or chronic biliary pathology.

Exclusion Criteria:

  • None.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048575


Contacts
Layout table for location contacts
Contact: Norton Perez, MD 660154 norton.perez@hotmail.com
Contact: Emma I Rodriguez, MSc 660154 emmaisa1@hotmail.com

Locations
Layout table for location information
Colombia
Clinica Primavera
Villavicencio, Meta, Colombia, 50001
Hospital Departamental de Villavicencio
Villavicencio, Meta, Colombia, 50001
Sponsors and Collaborators
Hospital Departamental de Villavicencio
Cooperative University of Colombia
Clinica Primavera
Investigators
Layout table for investigator information
Principal Investigator: Norton Perez, MD Cooperative University of Colombia
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Serna JC, Patiño S, Buriticá M, Osorio E, Morales CH, Toro JP. Incidencia de lesión de vías biliares en un hospital universitario: análisis de más de 1.600 colecistectomías laparoscópicas. Rev Colomb Cir. 2019;34(1):45-54.
Sanchez Beorlegui J, Monsalve Laguna E, Aspiroz Sancho A, Moreno de Marcos N. Colecistectomía laparoscópica en octogenarios. Rev Colomb Cir. 2008;23(3):136-45.
Castro F, Galindo J, Bejarano M. Complicaciones de colecistitis aguda en pacientes operados de urgencia. Rev Colomb Cir. 2008;23(1):15-21.
Domínguez LC, Herrera WE, Rivera AM, Bermúdez CE. Colecistectomía de urgencia por laparoscopia por colecistitis aguda en adultos mayores. Rev Colomb Cir. 2011;26:93-100.
Díaz S, Correa MJ, Giraldo LM, Ríos DC, Solórzano F, Wolff JD, et al. Experiencia en colecistectomía por laparoscopia en la Clínica Universitaria CES. Rev Colomb Cir. 2012;27(4):275-80.
Gaitán JA, Martínez VM. Enfermedad litiásica biliar, experiencia en una clínica de cuarto nivel, 2005-2011. Rev Colomb Cir. 2014;29(3):188-96.
Salinas C, López CA, Ramírez A, Torres R, Mendoza MC, Cuesta DP, et al. Colecistectomía por laparoscopia en colecistitis subaguda: análisis retrospectivo de pacientes en un hospital universitario. Rev Colomb Cir. 2018;33(2):154-61.
Ángel-González MS, Díaz-Quintero CA, Aristizábal-Arjona F, Turizo-Agamez Á, Molina-Céspedes I, Velásquez-Martínez MA, et al. Controversias en el manejo de la colecistitis aguda tardía. Rev Colomb Cir. 2019;34(4):364-71.
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.
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.
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.
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.
Toro-Calle J, Guzmán-Arango C, Ramírez-Ceballos M, Guzmán-Arango N, Toro-Calle J, Guzmán-Arango C, et al. ¿Son los criterios de la ASGE suficientes para la estratificación del riesgo de coledocolitiasis? Rev Colomb Gastroenterol. 2020;35(3):304-10.

Layout table for additonal information
Responsible Party: Norton Perez-Gutierrez, MD, Principal investigator, Hospital Departamental de Villavicencio
ClinicalTrials.gov Identifier: NCT06048575    
Other Study ID Numbers: GRIVI_2023_04_Cholecystitis
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: According to the decision of the ethical committee, the database might be stored in the repository of the university.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio:
Acute Cholecystitis
Gallbladder Diseases
Cholecystolithiasis
Biliary Tract Surgical Procedures
 Laparoscopy
Conversion to Open Surgery
Hospital Surgery Department
Colombia
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholecystitis
Acalculous Cholecystitis
Biliary Tract Diseases
Gallbladder Diseases
Digestive System Diseases