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CompletedNCT01068340Updated May 12, 2016

Early Small Bowel Obstruction Following Laparotomy For Trauma

An observational study in Small Bowel Obstruction, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by University of Southern California · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
571
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Small Bowel Obstruction

Keywords

  • Adhesions
  • Small Bowel Obstruction
  • Ileus
03

In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's enrollment of 571 is above the median of 152 across 68 observational studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing an exploratory laparotomy for trauma

Inclusion criteria

  • Exploratory laparotomy
  • Survival > 72 hours

Exclusion criteria

Exclusion Criteria:

  • No exploratory laparotomy
  • Survival \<= 72 hours
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
571 participants (actual)

Groups and 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

06

What researchers measure

Primary outcomes

  1. Small Bowel Obstruction not requiring surgical intervention

    Time frame: 30 days

Secondary outcomes

  1. Ileus

    Time frame: 30 days

  2. Hospital length of stay

    Time frame: 30 days

  3. Intensive Care Unit length of stay

    Time frame: 30 days

07

Study locations

1 site
  • Los Angeles County + University of Southern California Medical Center
    Los Angeles, California 90033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01068340
Lead sponsor
University of Southern California
Responsible party
Demetrios Demetriades (Chief of Division of Acute Care Surgery and Surgical Critical Care, University of Southern California) — Principal investigator
First posted
Feb 12, 2010
Start date
Jan 2010
Primary completion
Apr 2010
Completion
Jun 2010
Last update
May 12, 2016

Study contacts

Demetrios Demetriades, MD, PhD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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