Clinical trial NCT00937118: Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries
Official title: Damage Control for Severe Duodenal and Combined Duodenal-Pancreatic Injuries: A Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury of Duodenum
Pancreatic Injury
Keywords: laparotomy
duodenal injury
pancreatic injury
trauma
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients who received a trauma laparotomy for a duodenal or combined duodenal/pancreatic injury

Brief summary: The management of significant duodenal injuries and combined duodenal-pancreatic injuries continues to be challenging and controversial, and several techniques have been advocated over the years. One technique surgeons employ is the damage control/planned reoperation strategy. At the trauma center, the advent of damage control and other planned re-operation strategies has resulted in an evolution in the investigators management of duodenal lacerations and combined duodenal-pancreatic injuries. In this retrospective review, the investigators intend to quantify the investigators change in practice and to report its outcome compared to previous practice.

Using the OHSU Trauma Laparotomy Outcomes Database, the investigators will identify all patients receiving trauma laparotomy for a duodenal or duodenal/pancreatic injury for a period of 20 years, from 1989-2009. A number of data points will be retrieved from patients' medical records, including but not limited to grade of duodenal injury, mechanism of injury, Injury Severity Score, and others.

Detailed description: The management of significant duodenal injuries and combined duodenal-pancreatic injuries continues to be challenging and controversial. Several techniques have been advocated over the years to prevent the dreaded complications of repair breakdown, fistulization, and intra-abdominal sepsis. These include duodenal diverticulization, triple tube ostomy, tube duodenostomy, and pyloric exclusion. These techniques are all designed to decompress, heal without undue intraluminal pressure or flow. Recently, surgeons have questioned whether aggressive adjunctive diversion is truly necessary, especially for less severe injuries, and many have noted complications associated with the reconstructions apart from the injury.

An alternative to routine diversion/decompression/exclusion is the damage control/planned reoperation strategies following laparotomy for severe visceral injuries that have become prevalent in the past two decades. Instead of performing a primary duodenal repair with enteral diversion or decompression in a single operation, many surgeons employ a surveillance and "touch-up" strategy over the course of 2-4 abdominal explorations. The abdominal fascia is not closed until the healing phase has commenced and the surgeon feels confident the repair will hold.

At the trauma center, the advent of damage control and other planned re-operation strategies as resulted in an evolution in our management of duodenal lacerations and combined duodenal-pancreatic injuries. The investigators perform noticeably fewer decompression, diversion, or exclusion procedures and have increasingly relied on serial abdominal explorations for surveillance of the repair.

In this retrospective review, we intend to quantify our change in practice and to report its outcome compared to previous practice.

Using the OHSU Trauma Laparotomy Outcomes Database, we will identify all patients receiving trauma laparotomy in which a duodenal or combined duodenal-pancreatic injury was identified in a 20-year period from 1989-2009. The medical records of these patients will be reviewed to confirm duodenal injury and to tabulate other factors.

The patients will be categorized based on management of the duodenal injury, e.g. primary repair, decompression, diversion, or exclusion. Patients will also be categorized according to laparotomy strategy, e.g. damage control, planned reoperation, or primary fascial closure without planned reoperation. Duodenal-related complications will be tabulated and the various groups compared. The investigators anticipate including up to 50 patients.

Eligibility criteria: Inclusion Criteria:

* Trauma patients who received a trauma laparotomy for a duodenal or combined duodenal/pancreatic injury

Exclusion Criteria:

* None

Primary outcomes:
measure: Duodenal-related Complications
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: John C Mayberry, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mayberry J, Fabricant L, Anton A, Ham B, Schreiber M, Mullins R. Management of full-thickness duodenal laceration in the damage control era: evolution to primary repair without diversion or decompression. Am Surg. 2011 Jun;77(6):681-5.