What is this study trying to find out about penetrating abdominal trauma?

This study is evaluating whether alcohol, psychoactive drugs, or prior pain medication affect clinical evaluation and surgical decisions in patients with penetrating abdominal trauma. It compares patients with and without these exposures to see if physical exams remain reliable. The study is sponsored by Fundacion Clinica Valle del Lili and aims to improve trauma care protocols.

Who may be eligible for this penetrating abdominal trauma clinical trial?

Anyone aged 15 or older with penetrating abdominal trauma who is treated at the participating trauma centers may be eligible. Patients must not have been transferred after surgery or be declared dead on arrival. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this penetrating abdominal trauma clinical trial?

Study-related care, including all standard treatments and trial visits, is provided at no cost. However, personal travel expenses vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Age: 15Years +

All Genders

ID07330349

Impact of Alcohol, Psychoactive Drugs, and Pain Medications on Evaluation and Surgery Decisions in Patients 15 Years and Older with Penetrating Abdominal Trauma

Led by Fundacion Clinica Valle del Lili · Updated on 2026-01-09

363

Participants Needed

Research Sites

5 weeks

Total Duration

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

Age: 15Years +

All Genders

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.

Research Team

Sergio I Prada Ríos, PhD

Alberto F García, MD, MSc

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