Early Small Bowel Obstruction Following Laparotomy For Trauma

Small Bowel Obstruction Clinical Trial

Official title:

Retrospective Review of the Incidence of Early Small Bowel Obstruction in Patients Undergoing an Exploratory Laparotomy Following Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068340
• Other study ID #: EPSBO_TRAUMA_2010
• Status: Completed
• Phase: N/A
• First received: February 11, 2010
• Last updated: May 11, 2016
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: May 2016
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Exploratory laparotomy

• Survival > 72 hours

Exclusion Criteria:

• No exploratory laparotomy

• Survival <= 72 hours

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Locations

Country	Name	City	State
United States	Los Angeles County + University of Southern California Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small Bowel Obstruction not requiring surgical intervention		30 days	No
Secondary	Ileus		30 days	No
Secondary	Hospital length of stay		30 days	Yes
Secondary	Intensive Care Unit length of stay		30 days	No