Clinical trial Recruiting at 2 sites Observational Ages 15 and up

How alcohol, drugs, and pain medicines affect evaluation after a stab or gunshot to the belly

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

Run by Fundacion Clinica Valle del Lili · NCT07330349 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages15 Years and up
SexAll
Enrollment363 (estimated)
SponsorFundacion Clinica Valle del Lili
Academic / other
Locations2 sites (Cali, Valle del Cauca Department and 1 other locations)
StatusRecruiting
StartedNovember 25, 2020
Main results expectedDecember 24, 2025
Study endsJanuary 30, 2026
Registry record updatedJanuary 9, 2026
Trial IDNCT07330349 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Existing evidence is limited and mixed, with few prospective data, so this observational approach addresses a relatively under-studied question in trauma care.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.