RecruitingNCT07330349

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

Influence of Alcohol, Psychoactive Drugs, and Analgesic Administration on the Evaluation Process in Patients With Penetrating Abdominal Trauma


Sponsor

Fundacion Clinica Valle del Lili

Enrollment

363 participants

Start Date

Nov 25, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 15 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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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Interventions

OTHERAlcohol consumption

Alcohol consumption prior to hospital admission, identified through patient report, clinical assessment, or laboratory testing when available, and observed as part of routine trauma care, not assigned by the study.

OTHERPsychoactive substance use

Use of psychoactive substances prior to hospital admission, identified through clinical history, physical examination, or toxicology screening when available, and observed without modification by the study protocol.

OTHERAnalgesic administration

Administration of analgesic medications prior to or during initial hospital evaluation as part of standard trauma care, not assigned, standardized, or modified by the study.


Locations(2)

Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

Hospital Universitario del Valle Evaristo García

Cali, Valle del Cauca Department, Colombia

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