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

NCT07330349 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 363

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Abdominal Injuries
  • Alcohol Intoxication
  • Substance-related Disorders
  • Penetrating Abdominal Trauma

Interventions

OTHER

Psychoactive 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.

OTHER

Alcohol 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.

OTHER

Analgesic 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.

Sponsors & Collaborators

  • Hospital Universitario del Valle Evaristo Garcia

    collaborator UNKNOWN
  • Fundacion Clinica Valle del Lili

    lead OTHER

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2025-12-24
Completion
2026-01-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330349 on ClinicalTrials.gov