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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorFundacion Clinica Valle del Lili

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population includes patients aged 14 years and older presenting with penetrating abdominal trauma to two university-affiliated trauma centers in Cali, Colombia (one public and one private). Patients are evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated. The study assesses the impact of alcohol consumption, psychoactive substance use, and analgesic administration on the clinical evaluation process and surgical decision-making during hospitalization.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Alcohol consumption

    Other intervention

    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.

  • Psychoactive substance use

    Other intervention

    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.

  • Analgesic administration

    Other intervention

    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.

Treatment groups

363 Participants
are divided into 1 treatment group
Group A: Patients with Penetrating Abdominal Trauma3 interventions

Trial outcomes

Primary outcomes

1

Time to surgical decision

Time elapsed from hospital admission to the clinical decision to proceed with surgical intervention, measured in hours, based on standard trauma care assessment.

Time frame
Up to 28 days

Secondary outcomes

1

Need for surgical intervention

Requirement of operative management during hospital stay.

Time frame
Up to 28 days
2

Time to surgery

Time elapsed from hospital admission to the start of surgical intervention, measured in hours.

Time frame
Up to 28 days
3

In-hospital mortality

Death occurring during the index hospitalization.

Time frame
During hospitalization (Up to 28 days)
4

Trauma severity

Trauma severity will be assessed using ATI (Abdominal trauma index).

Time frame
28 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Clinica Valle del Lili

Lead sponsor

Hospital Universitario del Valle Evaristo Garcia

Collaborator