- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06048575
Cholecystitis in Villavicencio Hospitals
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Meta Department
-
Villavicencio, Meta Department, Colombia, 50001
- Clinica Primavera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients admitted with acute or chronic biliary pathology.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Number of patients with early therapy
Patients with early surgery (<72 hours of admission).
|
Early or late surgery, ambulatory, emergency, or differed.
|
|
Number of patients with subacute therapy
Patients with surgery for three days or more.
|
Early or late surgery, ambulatory, emergency, or differed.
|
|
Number of patients with late therapy
Patients with surgery beyond ten days.
|
Early or late surgery, ambulatory, emergency, or differed.
|
|
Number of patients with no therapy
Patients discharged with no surgical therapy.
|
Early or late surgery, ambulatory, emergency, or differed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 28 days
|
Number of patients deceased due to the biliary disease, complications, or other conditions.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital length of stay
Time Frame: 28 days
|
Number of days before discharge.
|
28 days
|
|
Need of ICU
Time Frame: 28 days
|
Patients admitted to ICU under any circumstance.
|
28 days
|
|
ICU length of stay
Time Frame: 28 days
|
Number of days hospitalized in ICU
|
28 days
|
|
Surgical site infection
Time Frame: 28 days
|
Number of patients with infections associated with the procedure (superficial, deep, organ/space)
|
28 days
|
|
Need of mechanical ventilation
Time Frame: 28 days
|
Number of patients needing mechanical ventilation
|
28 days
|
|
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
|
28 days
|
|
Surgical complications
Time Frame: 28 days
|
Number of patients with complications related to the surgical procedure
|
28 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Norton Perez, MD, Cooperative University of Colombia
Publications and helpful links
General Publications
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- 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.
- 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.
- 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.
- 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.
- Rodriguez-Sanjuan JC, Arruabarrena A, Sanchez-Moreno L, Gonzalez-Sanchez F, Herrera LA, Gomez-Fleitas M. Acute cholecystitis in high surgical risk patients: percutaneous cholecystostomy or emergency cholecystectomy? Am J Surg. 2012 Jul;204(1):54-9. doi: 10.1016/j.amjsurg.2011.05.013. Epub 2011 Oct 13.
- Simorov A, Ranade A, Parcells J, Shaligram A, Shostrom V, Boilesen E, Goede M, Oleynikov D. Emergent cholecystostomy is superior to open cholecystectomy in extremely ill patients with acalculous cholecystitis: a large multicenter outcome study. Am J Surg. 2013 Dec;206(6):935-40; discussion 940-1. doi: 10.1016/j.amjsurg.2013.08.019. Epub 2013 Oct 8.
- Madni TD, Leshikar DE, Minshall CT, Nakonezny PA, Cornelius CC, Imran JB, Clark AT, Williams BH, Eastman AL, Minei JP, Phelan HA, Cripps MW. The Parkland grading scale for cholecystitis. Am J Surg. 2018 Apr;215(4):625-630. doi: 10.1016/j.amjsurg.2017.05.017. Epub 2017 Jun 6.
- Lee W, Jang JY, Cho JK, Hong SC, Jeong CY. Does surgical difficulty relate to severity of acute cholecystitis? Validation of the parkland grading scale based on intraoperative findings. Am J Surg. 2020 Apr;219(4):637-641. doi: 10.1016/j.amjsurg.2018.12.005. Epub 2018 Dec 8.
- Choi SB, Han HJ, Kim CY, Kim WB, Song TJ, Suh SO, Kim YC, Choi SY. Early laparoscopic cholecystectomy is the appropriate management for acute gangrenous cholecystitis. Am Surg. 2011 Apr;77(4):401-6.
- Caputo P, Rossi G, Faccini M, Carzaniga P. Overcoming of a "surgical dogma" in acute cholecystitis treated in postponed emergency. Ann Ital Chir. 2009 Jul-Aug;80(4):287-92.
- Clavien PA, Strasberg SM. Severity grading of surgical complications. Ann Surg. 2009 Aug;250(2):197-8. doi: 10.1097/SLA.0b013e3181b6dcab. No abstract available.
- Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
- Cooper S, Donovan M, Grieve DA. Outcomes of percutaneous cholecystostomy and predictors of subsequent cholecystectomy. ANZ J Surg. 2018 Jul-Aug;88(7-8):E598-E601. doi: 10.1111/ans.14251. Epub 2017 Oct 20.
- Chen H, Jorissen R, Walcott J, Nikfarjam M. Incidence and predictors of common bile duct stones in patients with acute cholecystitis: a systematic literature review and meta-analysis. ANZ J Surg. 2020 Sep;90(9):1598-1603. doi: 10.1111/ans.15565. Epub 2019 Nov 19.
- Abi-Haidar Y, Sanchez V, Williams SA, Itani KM. Revisiting percutaneous cholecystostomy for acute cholecystitis based on a 10-year experience. Arch Surg. 2012 May;147(5):416-22. doi: 10.1001/archsurg.2012.135.
- Felicio SJO, Matos EP, Cerqueira AM, Farias KWSF, Silva RA, Torres MO. MORTALITY OF URGENCY VERSUS ELECTIVE VIDEOLAPAROSCOPIC CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS. Arq Bras Cir Dig. 2017 Jan-Mar;30(1):47-50. doi: 10.1590/0102-6720201700010013.
- Wang L, Yu HF, Guo T, Xie P, Zhang ZW, Yu YH. Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis with Mild Pancreatitis. Curr Med Sci. 2020 Oct;40(5):937-942. doi: 10.1007/s11596-020-2275-0. Epub 2020 Oct 29.
- Dimou FM, Adhikari D, Mehta HB, Riall TS. Outcomes in Older Patients with Grade III Cholecystitis and Cholecystostomy Tube Placement: A Propensity Score Analysis. J Am Coll Surg. 2017 Apr;224(4):502-511.e1. doi: 10.1016/j.jamcollsurg.2016.12.021. Epub 2017 Jan 6.
- Nassar AHM, Khan KS, Ng HJ, Sallam M. Operative Difficulty, Morbidity and Mortality Are Unrelated to Obesity in Elective or Emergency Laparoscopic Cholecystectomy and Bile Duct Exploration. J Gastrointest Surg. 2022 Sep;26(9):1863-1872. doi: 10.1007/s11605-022-05344-7. Epub 2022 May 31.
- Nasr MM. An Innovative Emergency Laparoscopic Cholecystectomy Technique; Early Results Towards Complication Free Surgery. J Gastrointest Surg. 2017 Feb;21(2):302-311. doi: 10.1007/s11605-016-3308-7. Epub 2016 Oct 25.
- Strasberg SM. Avoidance of biliary injury during laparoscopic cholecystectomy. J Hepatobiliary Pancreat Surg. 2002;9(5):543-7. doi: 10.1007/s005340200071.
- Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.
- Panni RZ, Chatterjee D, Panni UY, Robbins KJ, Liu J, Strasberg SM. Sequential histologic evolution of gallbladder inflammation in acute cholecystitis over the first 10 days after onset of symptoms. J Hepatobiliary Pancreat Sci. 2023 Jun;30(6):724-736. doi: 10.1002/jhbp.1274. Epub 2022 Dec 1.
- Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF; Tokyo Guidelines Revision Committee. New diagnostic criteria and severity assessment of acute cholecystitis in revised Tokyo Guidelines. J Hepatobiliary Pancreat Sci. 2012 Sep;19(5):578-85. doi: 10.1007/s00534-012-0548-0.
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- Welsh S, Nassar AHM, Sallam M. The incidence, operative difficulty and outcomes of staged versus index admission laparoscopic cholecystectomy and bile duct exploration for all comers: a review of 5750 patients. Surg Endosc. 2022 Nov;36(11):8221-8230. doi: 10.1007/s00464-022-09272-0. Epub 2022 May 4.
- Borzellino G, Sauerland S, Minicozzi AM, Verlato G, Di Pietrantonj C, de Manzoni G, Cordiano C. Laparoscopic cholecystectomy for severe acute cholecystitis. A meta-analysis of results. Surg Endosc. 2008 Jan;22(1):8-15. doi: 10.1007/s00464-007-9511-6. Epub 2007 Aug 18.
- Huang SZ, Chen HQ, Liao WX, Zhou WY, Chen JH, Li WC, Zhou H, Liu B, Hu KP. Comparison of emergency cholecystectomy and delayed cholecystectomy after percutaneous transhepatic gallbladder drainage in patients with acute cholecystitis: a systematic review and meta-analysis. Updates Surg. 2021 Apr;73(2):481-494. doi: 10.1007/s13304-020-00894-4. Epub 2020 Oct 13.
- Derici H, Kara C, Bozdag AD, Nazli O, Tansug T, Akca E. Diagnosis and treatment of gallbladder perforation. World J Gastroenterol. 2006 Dec 28;12(48):7832-6. doi: 10.3748/wjg.v12.i48.7832.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRIVI_2023_04_Cholecystitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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