Clinical Trial

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

Study acronym: DIRECT
Recruiting
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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.
Trial Details
NCT Number NCT07330349
Lead Sponsor Fundacion Clinica Valle del Lili
Collaborators: Hospital Universitario del Valle Evaristo Garcia
Conditions Abdominal Injuries, Alcohol Intoxication, Substance-related Disorders, Penetrating Abdominal Trauma
Enrollment 363 participants
Start Date 2020-11-25
Primary Completion 2025-12-24 (estimated)
Study Completion 2026-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-09