Biliary Tract DiseasesNCT06048575
Cholecystitis in Villavicencio Hospitals
An observational study of Biliary Tract Diseases, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Biliary Tract Diseases
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 609 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients admitted with acute or chronic biliary pathology.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of the Attention Provided to Patients With Cholecystitis in Villavicencio Hospitals, Colombia: A Retrospective Cross-sectional Trial.
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.
Read more
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.
Read the 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.
- Conditions
- Biliary Tract Diseases
- Being tested
- Cholecystectomy
- Keywords
- Acute Cholecystitis, Gallbladder Diseases, Cholecystolithiasis, Biliary Tract Surgical Procedures, Laparoscopy, Conversion to Open Surgery, Hospital Surgery Department, Colombia
- Medical subject headings
- Biliary Tract Diseases, Cholecystitis, Acute, Gallbladder Diseases, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Early or late surgery, ambulatory, emergency, or differed.
| Study group | Role | What they receive |
|---|---|---|
| Number of patients with early therapy | Patients with early surgery (<72 hours of admission). Receives: Procedure: Cholecystectomy | |
| Number of patients with subacute therapy | Patients with surgery for three days or more. Receives: Procedure: Cholecystectomy | |
| Number of patients with late therapy | Patients with surgery beyond ten days. Receives: Procedure: Cholecystectomy | |
| Number of patients with no therapy | Patients discharged with no surgical therapy. Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of patients deceased due to the biliary disease, complications, or other conditions.
Measured: 28 days
Secondary outcomes (7)
Hospital length of stay
Number of days before discharge.
Measured: 28 days
Need of ICU
Patients admitted to ICU under any circumstance.
Measured: 28 days
ICU length of stay
Number of days hospitalized in ICU
Measured: 28 days
Surgical site infection
Number of patients with infections associated with the procedure (superficial, deep, organ/space)
Measured: 28 days
Need of mechanical ventilation
Number of patients needing mechanical ventilation
Measured: 28 days
Complicated presentation
Number of patients with complications of the disease previous or during hospitalization, but not related to the surgical procedure
Measured: 28 days
Surgical complications
Number of patients with complications related to the surgical procedure
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Aug 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez, MD, Principal investigator, Cooperative University of Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048575
- Sponsor's protocol ID
- GRIVI_2023_04_Cholecystitis
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: According to the decision of the ethical committee, the database might be stored in the repository of the university.
Publications
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.
Busto Bea V, Caro Paton A, Aller Dela Fuente R, Gonzalez Sagrado M, Garcia-Alonso FJ, Perez-Miranda Castillo M. Acute calculous cholecystitis: a real-life management study in a tertiary teaching hospital. Rev Esp Enferm Dig. 2019 Sep;111(9):667-671. doi: 10.17235/reed.2019.6260/2019.
PubMed 31317760Janikow 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.
PubMed 28657526
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of the Attention Provided to Patients With Cholecystitis in Villavicencio Hospitals, Colombia: A Retrospective Cross-sectional Trial.
- ClinicalTrials.gov ID
- NCT06048575
- Acronym / sponsor ID
- GRIVI_2023_04_Cholecystitis
- Conditions
- Biliary Tract Diseases
- Keywords
- Acute Cholecystitis, Gallbladder Diseases, Cholecystolithiasis, Biliary Tract Surgical Procedures, Laparoscopy, Conversion to Open Surgery, Hospital Surgery Department, Colombia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Number of patients with early therapy | – | Procedure: CholecystectomyPatients with early surgery (<72 hours of admission). |
| Number of patients with subacute therapy | – | Procedure: CholecystectomyPatients with surgery for three days or more. |
| Number of patients with late therapy | – | Procedure: CholecystectomyPatients with surgery beyond ten days. |
| Number of patients with no therapy | – | Procedure: CholecystectomyPatients discharged with no surgical therapy. |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients admitted with acute or chronic biliary pathology.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecystectomyEarly or late surgery, ambulatory, emergency, or differed. | Procedure or surgery | Number of patients with early therapy, Number of patients with late therapy, Number of patients with no therapy, Number of patients with subacute therapy |
Primary outcome
Mortality
Time frame: 28 days
Number of patients deceased due to the biliary disease, complications, or other conditions.
7 secondary outcomes
Hospital length of stay
Time frame: 28 days
Need of ICU
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Surgical site infection
Time frame: 28 days
Need of mechanical ventilation
Time frame: 28 days
Complicated presentation
Time frame: 28 days
Surgical complications
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publicationSerna 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.
- Results publicationSanchez Beorlegui J, Monsalve Laguna E, Aspiroz Sancho A, Moreno de Marcos N. Colecistectomía laparoscópica en octogenarios. Rev Colomb Cir. 2008;23(3):136-45.
- Results publicationCastro F, Galindo J, Bejarano M. Complicaciones de colecistitis aguda en pacientes operados de urgencia. Rev Colomb Cir. 2008;23(1):15-21.
- Results publicationDomínguez 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.
- Results publicationDíaz 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.
- Results publicationGaitán JA, Martínez VM. Enfermedad litiásica biliar, experiencia en una clínica de cuarto nivel, 2005-2011. Rev Colomb Cir. 2014;29(3):188-96.
- Results publicationSalinas 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.
- Results publicationÁngel-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.
- Results publicationArroyave 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.
- Results publicationBustos-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.
- Results publicationVargas 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.
- Results publicationYurgaky-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.
- Individual participant dataSharing planned: Undecided. According to the decision of the ethical committee, the database might be stored in the repository of the university.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norton Perez, MD principal investigator
Cooperative University of Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Diseases, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048575, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.