Early Small Bowel Obstruction Following Laparotomy For Trauma

NCT01068340 | Completed

• 1 other identifier: EPSBO_TRAUMA_2010
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Bowel Obstruction

Keywords

Adhesions; Small Bowel Obstruction; Ileus

Outcome Measures

Primary Outcomes (1)

• Small Bowel Obstruction not requiring surgical intervention

  30 days

Secondary Outcomes (3)

• Ileus

  30 days

• Hospital length of stay

  30 days

• Intensive Care Unit length of stay

  30 days

Study Arms (2)

SBO Patients

Patients who develop small bowel obstruction requiring or not surgical intervention

No SBO Patients

Patients who do not develop small bowel obstruction

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing an exploratory laparotomy for trauma

You may qualify if:

• Exploratory laparotomy
• Survival \> 72 hours

You may not qualify if:

• No exploratory laparotomy
• Survival \<= 72 hours

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County + University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Tissue Adhesions; Ileus

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Demetrios Demetriades, MD, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Acute Care Surgery and Surgical Critical Care

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)