NCT07330349 Alcohol, Psychoactive Drugs, Analgesics and Evaluation in Penetrating Abdominal Trauma

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 363 participants in total. It began in 2020-11-25 with a primary completion date of 2025-12-24.

Brief Summary

This prospective observational study aims to evaluate whether alcohol consumption, psychoactive drug use, or prior administration of analgesics affects the clinical evaluation and surgical decision-making process in patients with penetrating abdominal trauma. The study will be conducted in two level I trauma centers in Cali, Colombia: a public university hospital and a private university hospital, both with high volumes of trauma patients and established protocols for non-operative management using serial physical examination. In many trauma centers, serial physical examination is used to safely identify patients who require surgical intervention. However, there is concern that intoxication or altered mental status may reduce the reliability of physical examination, potentially leading to unnecessary imaging studies, delays in surgical decision-making, or non-therapeutic laparotomies. Despite this concern, available evidence supporting these assumptions is limited. Patients older than 14 years with penetrating abdominal trauma who undergo clinical evaluation to decide on surgical intervention. Patients will be classified according to the presence or absence of alcohol consumption, psychoactive substance use, or prior analgesic administration. The primary outcome is the time from hospital admission to the decision for surgical intervention. Secondary outcomes include trauma severity, need for surgery, length of hospital and intensive care unit stay, complications, and mortality. By comparing patients with and without substance exposure across two different trauma care settings, this study seeks to determine whether serial physical examination remains a reliable and safe method for clinical decision-making in this population. The results may help optimize evaluation strategies, reduce unnecessary surgical procedures and diagnostic tests, and improve the standardization of care for patients with penetrating abdominal trauma.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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