Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries

NCT ID: NCT00937118

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-11-30

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.

Conditions

Injury of Duodenum; Pancreatic Injury

Keywords

laparotomy; duodenal injury; pancreatic injury; trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

John C. Mayberry

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Mayberry, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Rotondo MF, Schwab CW, McGonigal MD, Phillips GR 3rd, Fruchterman TM, Kauder DR, Latenser BA, Angood PA. 'Damage control': an approach for improved survival in exsanguinating penetrating abdominal injury. J Trauma. 1993 Sep;35(3):375-82; discussion 382-3.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 9841741 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21679632 (View on PubMed)

Other Identifiers

IRB # 5128

Identifier Type: -

Identifier Source: org_study_id