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Early Small Bowel Obstruction Following Laparotomy For Trauma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068340
First Posted: February 12, 2010
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Demetrios Demetriades, University of Southern California
  Purpose

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.


Condition
Small Bowel Obstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Review of the Incidence of Early Small Bowel Obstruction in Patients Undergoing an Exploratory Laparotomy Following Trauma

Resource links provided by NLM:


Further study details as provided by Demetrios Demetriades, University of Southern California:

Primary Outcome Measures:
  • Small Bowel Obstruction not requiring surgical intervention [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Ileus [ Time Frame: 30 days ]
  • Hospital length of stay [ Time Frame: 30 days ]
  • Intensive Care Unit length of stay [ Time Frame: 30 days ]

Enrollment: 571
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
SBO Patients
Patients who develop small bowel obstruction requiring or not surgical intervention
No SBO Patients
Patients who do not develop small bowel obstruction

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing an exploratory laparotomy for trauma
Criteria

Inclusion Criteria:

  • Exploratory laparotomy
  • Survival > 72 hours

Exclusion Criteria:

  • No exploratory laparotomy
  • Survival <= 72 hours
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068340


Locations
United States, California
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Demetrios Demetriades, MD, PhD University of Southern California
  More Information

Responsible Party: Demetrios Demetriades, Chief of Division of Acute Care Surgery and Surgical Critical Care, University of Southern California
ClinicalTrials.gov Identifier: NCT01068340     History of Changes
Other Study ID Numbers: EPSBO_TRAUMA_2010
First Submitted: February 11, 2010
First Posted: February 12, 2010
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Demetrios Demetriades, University of Southern California:
Adhesions
Small Bowel Obstruction
Ileus

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases