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
  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 University of Southern California:

Primary Outcome Measures:
  • Small Bowel Obstruction not requiring surgical intervention [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 650
Study Start Date: January 2010
Estimated Study Completion Date: June 2010
Estimated 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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068340

Contacts
Contact: Demetrios Demetriades, MD, PhD (323) 409 7761 demetria@usc.edu
Contact: Galinos Barmparas, MD (323) 409 8596 galinos.barmparas@gmail.com

Locations
United States, California
Los Angeles County + University of Southern California Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Demetrios Demetriades, MD, PhD    323-409-7761    demetria@usc.edu   
Contact: Galinos Barmparas, MD    (323) 409 8596    galinos.barmparas@gmail.com   
Principal Investigator: Demetrios Demetriades, MD, PhD         
Sub-Investigator: Galinos Barmparas, MD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Demetrios Demetriades, MD, PhD University of Southern California
  More Information

No publications provided

Responsible Party: Demetrios Demetriades, MD, PhD, Los Angeles County+University of Southern California Medical Center
ClinicalTrials.gov Identifier: NCT01068340     History of Changes
Other Study ID Numbers: EPSBO_TRAUMA_2010
Study First Received: February 11, 2010
Last Updated: February 11, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 01, 2014