Condition: Abdominal Injuries · Alcohol Intoxication · Substance-related Disorders · Sponsor: Fundacion Clinica Valle del Lili
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 morta…
This description comes directly from the study's public registry record.
Sergio I Prada Ríos, PhD · +57 6023319090 · sergio.prada@fvl.org.co
Alberto F García, MD, MSc · +57 3154676870 · alberto.garcia@fvl.org.co
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| Fundación Valle del Lili | Cali, Valle del Cauca Department, Colombia | Recruiting |
| Hospital Universitario del Valle Evaristo García | Cali, Valle del Cauca Department, Colombia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07330349