Early Small Bowel Obstruction Following Laparotomy For Trauma
Recruitment status was Recruiting
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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 |
- Small Bowel Obstruction not requiring surgical intervention [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- 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 |
Patients undergoing an exploratory laparotomy for trauma
Inclusion Criteria:
- Exploratory laparotomy
- Survival > 72 hours
Exclusion Criteria:
- No exploratory laparotomy
- Survival <= 72 hours
Contacts and Locations| Contact: Demetrios Demetriades, MD, PhD | (323) 409 7761 | demetria@usc.edu |
| Contact: Galinos Barmparas, MD | (323) 409 8596 | galinos.barmparas@gmail.com |
| 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 | |
| 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 May 23, 2013