Clinical trial NCT01068340: Early Small Bowel Obstruction Following Laparotomy For Trauma
Official title: Retrospective Review of the Incidence of Early Small Bowel Obstruction in Patients Undergoing an Exploratory Laparotomy Following Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Obstruction
Keywords: Adhesions
Small Bowel Obstruction
Ileus
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 571
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing an exploratory laparotomy for trauma

Brief summary: The formation of intraperitoneal adhesion following abdominal surgery is accepted by clinicians as an inevitable consequence. More than 90% of patients undergoing a surgical procedure in the abdomen will develop intraperitoneal adesions. The incidence however, of small bowel obstruction (SBO) resulting form these adhesions is far lower. To date, it is unknown which risk factors predispose these patients to develop SBO. Several have been proposed, such as age, peritonitis, or surgery for small bowel injury resulting from gunshots. None of them however, has been widely accepted.

During the last 20 years the significant lifetime risks associated with this phenomenon and its impact on the quality of life of patients has been well recognized. In addition, the burden on healthcare resources due to complications caused by adhesions is increasing and medicolegal consequences are rapidly evolving.

Early SBO following laparotomy for trauma is a poorly described entity. A few retrospective, single institution studies with a low number of patients have tried to address this issue. However, these studies either included a subset of trauma patients, i.e. patients sustaining penetrating trauma,\[4\] or patients undergoing a negative or non-therapeutic laparotomy, or examined only the incidence of SBO requiring surgical intervention. In addition, recent data regarding this issue is lacking, especially after the implementation of the damage control concept and the other advances in trauma surgery.

The aim of this study is to define the incidence of early SBO following laparotomy for trauma and to examine possible risk factors associated with its development.

Detailed description: This is a retrospective review of all trauma patients admitted to the Los Angeles County - University of Southern California (LAC+USC) Medical Center from January 2006 to June 2009 (3.5 years). The trauma registry will be utilized to identify patients \>= 15 years old who underwent a laparotomy during the study period and survived \> 72 hours. For patients meeting inclusion criteria, all imaging studies obtained within the hospital course will be reviewed to identify patients who developed early SBO. The rationale for utilizing imaging studies is that obtaining these studies for patients with high suspicion of SBO is standard practice to establish the diagnosis. The charts of these patients will subsequently be reviewed and data will be collected using a predefined data collecting form.

Eligibility criteria: Inclusion Criteria:

* Exploratory laparotomy
* Survival \> 72 hours

Exclusion Criteria:

* No exploratory laparotomy
* Survival \<= 72 hours

Primary outcomes:
measure: Small Bowel Obstruction not requiring surgical intervention
timeFrame: 30 days
Secondary outcomes:
measure: Ileus
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Intensive Care Unit length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County + University of Southern California Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Demetrios Demetriades, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: