Influence of Alcohol, Psychoactive Drugs, and Analgesic Administration on the Evaluation Process in Patients With Penetrating Abdominal Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 363
- 试验地点
- 2
- 主要终点
- Time to surgical decision
研究概览
简要总结
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.
详细描述
This is a prospective observational cohort study designed to evaluate the impact of alcohol consumption, psychoactive drug use, and prior administration of analgesics on the clinical evaluation process and surgical decision-making in patients with penetrating abdominal trauma.
The study will be conducted at two level I trauma centers in Cali, Colombia: one public university hospital and one private university hospital. Both institutions manage a high volume of trauma patients and apply standardized protocols based on serial physical examination for the evaluation of patients with penetrating abdominal trauma.
Patients older than 14 years who present with penetrating abdominal trauma and are hemodynamically stable will be evaluated according to routine institutional protocols, including serial abdominal physical examinations and selective use of diagnostic adjuncts such as focused abdominal sonography for trauma (FAST) or computed tomography, when clinically indicated. No additional diagnostic or therapeutic interventions will be performed as part of the study.
The exposure of interest is the presence of alcohol consumption, psychoactive substance use, or prior administration of analgesics before or during the initial clinical evaluation. These exposures will be identified through clinical assessment and medical record review and will be categorized according to predefined operational definitions.
The primary analytical focus is the interval between hospital admission and the decision for surgical intervention. Secondary analyses will explore associations between substance exposure and trauma severity, need for operative management, length of hospital stay, intensive care unit admission and length of stay, postoperative complications, and in-hospital mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with Penetrating Abdominal Trauma
Patients presenting with penetrating abdominal trauma who are evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated.
干预措施: Alcohol consumption (Other)
Patients with Penetrating Abdominal Trauma
Patients presenting with penetrating abdominal trauma who are evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated.
干预措施: Psychoactive substance use (Other)
Patients with Penetrating Abdominal Trauma
Patients presenting with penetrating abdominal trauma who are evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated.
干预措施: Analgesic administration (Other)
结局指标
主要结局
Time to surgical decision
时间窗: Up to 28 days
Time elapsed from hospital admission to the clinical decision to proceed with surgical intervention, measured in hours, based on standard trauma care assessment.
次要结局
- Need for surgical intervention(Up to 28 days)
- Time to surgery(Up to 28 days)
- Intraoperative bleeding(28 days)
- In-hospital mortality(During hospitalization (Up to 28 days))
- Trauma severity(28 Days)
研究者
Alberto Federico García
Trauma and Acute Care Surgeon
Fundacion Clinica Valle del Lili