Cholecystitis in Villavicencio Hospitals

Biliary Tract Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06048575
• Other study ID #: GRIVI_2023_04_Cholecystitis
• Status: Not yet recruiting
• Start date: January 28, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Hospital Departamental de Villavicencio
• Contact: Norton Perez, MD
• Phone: 660154
• Email: norton.perez[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

Inclusion Criteria:

• Patients admitted with acute or chronic biliary pathology.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Cholecystitis

Intervention

Procedure:
• Cholecystectomy
Early or late surgery, ambulatory, emergency, or differed.

Locations

Country	Name	City	State
Colombia	Clinica Primavera	Villavicencio	Meta
Colombia	Hospital Departamental de Villavicencio	Villavicencio	Meta

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Departamental de Villavicencio	Clinica Primavera, Cooperative University of Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (48)

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. — View Citation

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):43

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 — View Citation

Bourikian S, Anand RJ, Aboutanos M, Wolfe LG, Ferrada P. Risk factors for acute gangrenous cholecystitis in emergency general surgery patients. Am J Surg. 2015 Oct;210(4):730-3. doi: 10.1016/j.amjsurg.2015.05.003. Epub 2015 Jun 27. — View Citation

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: — View Citation

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.

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. — View Citation

Castro F, Galindo J, Bejarano M. Complicaciones de colecistitis aguda en pacientes operados de urgencia. Rev Colomb Cir. 2008;23(1):15-21.

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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 201 — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — View Citation

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.

Endo I, Takada T, Hwang TL, Akazawa K, Mori R, Miura F, Yokoe M, Itoi T, Gomi H, Chen MF, Jan YY, Ker CG, Wang HP, Kiriyama S, Wada K, Yamaue H, Miyazaki M, Yamamoto M. Optimal treatment strategy for acute cholecystitis based on predictive factors: Japan- — View Citation

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. — View Citation

Gaitán JA, Martínez VM. Enfermedad litiásica biliar, experiencia en una clínica de cuarto nivel, 2005-2011. Rev Colomb Cir. 2014;29(3):188-96.

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 — View Citation

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 a — View Citation

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. — View Citation

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 — View Citation

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.2018.12.00 — View Citation

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.2017.05.0 — View Citation

Mercado MA. [From Langenbuch to Strasberg: the spectrum of bile duct injuries]. Rev Invest Clin. 2004 Sep-Oct;56(5):649-64. Spanish. — View Citation

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, — View Citation

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. — View Citation

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/s1160 — View Citation

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 — View Citation

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 — View Citation

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: 1 — View Citation

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.

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.

Schuster KM, O'Connor R, Cripps M, Kuhlenschmidt K, Taveras L, Kaafarani HM, El Hechi M, Puri R, Schroeppel TJ, Enniss TM, Cullinane DC, Cullinane LM, Agarwal S Jr, Kaups K, Crandall M, Tominaga G. Revision of the AAST grading scale for acute cholecystiti — View Citation

Serna JC, Patiño S, Buritica´ 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.

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. — View Citation

Strasberg SM. Avoidance of biliary injury during laparoscopic cholecystectomy. J Hepatobiliary Pancreat Surg. 2002;9(5):543-7. doi: 10.1007/s005340200071. — View Citation

Sugiura R, Nakamura H, Horita S, Meguro T, Sasaki K, Kagaya H, Yoshida T, Aoki H, Morita T, Fujita M, Tamoto E, Fukushima M, Ashitate Y, Ueno T, Tsutaho A, Kuwatani M, Sakamoto N. Assessment of postoperative common bile duct stones after endoscopic extrac — View Citation

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.

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 Gastro

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. — View Citation

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: — View Citation

Yokoe M, Takada T, Hwang TL, Endo I, Akazawa K, Miura F, Mayumi T, Mori R, Chen MF, Jan YY, Ker CG, Wang HP, Itoi T, Gomi H, Kiriyama S, Wada K, Yamaue H, Miyazaki M, Yamamoto M. Descriptive review of acute cholecystitis: Japan-Taiwan collaborative epidem — View Citation

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, — View Citation

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 Gastro

* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of patients deceased due to the biliary disease, complications, or other conditions.	28 days
Secondary	Hospital length of stay	Number of days before discharge.	28 days
Secondary	Need of ICU	Patients admitted to ICU under any circumstance.	28 days
Secondary	ICU length of stay	Number of days hospitalized in ICU	28 days
Secondary	Surgical site infection	Number of patients with infections associated with the procedure (superficial, deep, organ/space)	28 days
Secondary	Need of mechanical ventilation	Number of patients needing mechanical ventilation	28 days
Secondary	Complicated presentation	Number of patients with complications of the disease previous or during hospitalization, but not related to the surgical procedure	28 days
Secondary	Surgical complications	Number of patients with complications related to the surgical procedure	28 days