How alcohol, drugs, and pain medicines affect evaluation after a stab or gunshot to the belly
Influence of Alcohol, Psychoactive Drugs, and Analgesic Administration on the Evaluation Process in Patients With Penetrating Abdominal Trauma
This study will see if alcohol, psychoactive drugs, or pain medicines change how doctors evaluate and decide on surgery for people with penetrating abdominal injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 363 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Fundacion Clinica Valle del Lili Academic / other |
| Locations | 2 sites (Cali, Valle del Cauca Department and 1 other locations) |
| Trial ID | NCT07330349 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort enrolling patients aged 14 and older with penetrating abdominal trauma who are hemodynamically stable at two level I trauma centers in Cali, Colombia. Participants receive routine care with serial abdominal physical examinations and selective use of FAST or CT as indicated, while the team records whether alcohol, psychoactive substances, or analgesics were present before or during initial evaluation. The main analyses compare time from admission to surgical decision, use of diagnostic imaging, and rates of non-therapeutic laparotomy between exposed and unexposed patients. No additional diagnostic or therapeutic interventions are performed for study purposes; exposures are identified from clinical assessment and chart review using predefined definitions.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 or older who present with penetrating abdominal trauma and are hemodynamically stable at one of the participating centers.
Not a fit: Patients who are hemodynamically unstable, transferred after an initial operation, declared dead on arrival, or who lack sufficient clinical data are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians know when serial physical exams are reliable and reduce unnecessary imaging, delays to surgery, or non-therapeutic operations.
How similar studies have performed: Existing evidence is limited and mixed, with few prospective data, so this observational approach addresses a relatively under-studied question in trauma care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Cali, Valle del Cauca Department and 1 other locations
- Fundación Valle del Lili — Cali, Valle del Cauca Department, Colombia (Recruiting)
- Hospital Universitario del Valle Evaristo García — Cali, Valle del Cauca Department, Colombia (Recruiting)
Study contacts
- Study coordinator: Sergio I Prada Ríos, PhD
- Email: sergio.prada@fvl.org.co
- Phone: +57 6023319090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.