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)

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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

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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

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* 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