Early Small Bowel Obstruction Following Laparotomy For Trauma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Southern California.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01068340
First received: February 11, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 11, 2010
February 11, 2010
January 2010
April 2010   (final data collection date for primary outcome measure)
Small Bowel Obstruction not requiring surgical intervention [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Ileus [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Intensive Care Unit length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Small Bowel Obstruction Following Laparotomy For Trauma
Retrospective Review of the Incidence of Early Small Bowel Obstruction in Patients Undergoing an Exploratory Laparotomy Following Trauma

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients undergoing an exploratory laparotomy for trauma

Small Bowel Obstruction
Not Provided
  • SBO Patients
    Patients who develop small bowel obstruction requiring or not surgical intervention
  • No SBO Patients
    Patients who do not develop small bowel obstruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
June 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Exploratory laparotomy
  • Survival > 72 hours

Exclusion Criteria:

  • No exploratory laparotomy
  • Survival <= 72 hours
Both
15 Years and older
No
Contact: Demetrios Demetriades, MD, PhD (323) 409 7761 demetria@usc.edu
Contact: Galinos Barmparas, MD (323) 409 8596 galinos.barmparas@gmail.com
United States
 
NCT01068340
EPSBO_TRAUMA_2010
No
Demetrios Demetriades, MD, PhD, Los Angeles County+University of Southern California Medical Center
University of Southern California
Not Provided
Principal Investigator: Demetrios Demetriades, MD, PhD University of Southern California
University of Southern California
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP