Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John C. Mayberry, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00937118
First received: July 9, 2009
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition
Injury of Duodenum
Pancreatic Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Damage Control for Severe Duodenal and Combined Duodenal-Pancreatic Injuries: A Retrospective Review

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Duodenal-related Complications [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    Duodenal-related complications including leak, obstruction, and abscess


Enrollment: 43
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Injury Management
Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00937118

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: John C Mayberry, MD Oregon Health and Science University
  More Information

Publications:

Responsible Party: John C. Mayberry, Professor of Surgery, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00937118     History of Changes
Other Study ID Numbers: IRB # 5128
Study First Received: July 9, 2009
Results First Received: May 4, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
laparotomy
duodenal injury
pancreatic injury
trauma

ClinicalTrials.gov processed this record on September 22, 2014