Early Small Bowel Obstruction Following Laparotomy For Trauma

NCT ID: NCT01068340

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 571 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Small Bowel Obstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

SBO Patients

Patients who develop small bowel obstruction requiring or not surgical intervention

No interventions assigned to this group

No SBO Patients

Patients who do not develop small bowel obstruction

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Exploratory laparotomy
• Survival > 72 hours

Exclusion Criteria

• No exploratory laparotomy
• Survival <= 72 hours

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Demetrios Demetriades

Chief of Division of Acute Care Surgery and Surgical Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Demetrios Demetriades, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Los Angeles County + University of Southern California Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

EPSBO_TRAUMA_2010

Identifier Type: -

Identifier Source: org_study_id