Actively Recruiting
Influence of Alcohol, Psychoactive Drugs, and Analgesic Administration on the Evaluation Process in Patients With Penetrating Abdominal Trauma
Led by Fundacion Clinica Valle del Lili · Updated on 2026-01-09
363
Participants Needed
2
Research Sites
5 weeks
Total Duration
On this page
Sponsors
F
Fundacion Clinica Valle del Lili
Lead Sponsor
H
Hospital Universitario del Valle Evaristo Garcia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study how alcohol use, psychoactive drugs, or prior pain medication affect the clinical evaluation and surgical decisions for patients with penetrating abdominal trauma. It is conducted as a prospective observational study in two high-volume trauma centers in Cali, Colombia, including a public and a private university hospital. The study addresses concerns about whether intoxication or altered mental status might reduce the reliability of serial physical examinations, which are commonly used to decide if surgery is needed in these patients. Patients aged 15 years and older who have penetrating abdominal trauma and are hemodynamically stable will be evaluated using standard care protocols at these centers. This includes serial physical examinations and selective use of imaging tests like focused abdominal sonography or CT scans when necessary. The study does not add any extra procedures and classifies patients based on whether they consumed alcohol, used psychoactive substances, or received analgesics before evaluation. The main focus is the time from hospital admission to the decision for surgery, with other outcomes like trauma severity, surgery need, hospital stay length, complications, and mortality also being studied. Participants will be followed during their hospital stay, with data collected through electronic forms and verified for accuracy. Researchers will analyze the timing of surgical decisions and compare outcomes between patients with and without substance exposure. This study aims to provide evidence on the safety and reliability of serial physical examination in these trauma patients and may help improve trauma care protocols. The total observation period includes up to 28 days for surgical decision and related outcomes.
CONDITIONS
Brief Title
Alcohol, Psychoactive Drugs, Analgesics and Evaluation in Penetrating Abdominal Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting to the emergency department with penetrating abdominal trauma.
- Age 14 years or older.
- Patients evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated.
- Patients admitted to the participating trauma centers during the study period.
You will not qualify if you...
- Patients transferred from another institution after initial surgical intervention.
- Patients declared dead on arrival.
- Patients with incomplete or missing clinical data precluding assessment of outcomes of interest.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants who undergo routine trauma care for penetrating abdominal trauma are observed. Data on alcohol consumption, psychoactive substance use, and analgesic administration before or during initial evaluation are collected without affecting standard clinical management.
1 to 2 visits depending on clinical course
Trial Site Locations
Total: 2 locations
1
Fundación Valle del Lili
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
2
Hospital Universitario del Valle Evaristo García
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
Research Team
S
Sergio I Prada Ríos, PhD
A
Alberto F García, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here