NCT00937118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

August 12, 2013

Completed
Last Updated

August 12, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

July 9, 2009

Results QC Date

May 4, 2012

Last Update Submit

May 13, 2013

Conditions

Keywords

laparotomyduodenal injurypancreatic injurytrauma

Outcome Measures

Primary Outcomes (1)

  • Duodenal-related Complications

    Duodenal-related complications including leak, obstruction, and abscess

    20 years

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (10)

  • Stone HH, Fabian TC. Management of duodenal wounds. J Trauma. 1979 May;19(5):334-9. doi: 10.1097/00005373-197905000-00006.

    PMID: 448769BACKGROUND
  • Snyder WH 3rd, Weigelt JA, Watkins WL, Bietz DS. The surgical management of duodenal trauma. Precepts based on a review of 247 cases. Arch Surg. 1980 Apr;115(4):422-9. doi: 10.1001/archsurg.1980.01380040050009.

    PMID: 7362449BACKGROUND
  • Kashuk JL, Moore EE, Cogbill TH. Management of the intermediate severity duodenal injury. Surgery. 1982 Oct;92(4):758-64.

    PMID: 7123496BACKGROUND
  • Rickard MJ, Brohi K, Bautz PC. Pancreatic and duodenal injuries: keep it simple. ANZ J Surg. 2005 Jul;75(7):581-6. doi: 10.1111/j.1445-2197.2005.03351.x.

    PMID: 15972052BACKGROUND
  • Talving P, Nicol AJ, Navsaria PH. Civilian duodenal gunshot wounds: surgical management made simpler. World J Surg. 2006 Apr;30(4):488-94. doi: 10.1007/s00268-005-0245-0.

    PMID: 16547621BACKGROUND
  • Seamon MJ, Pieri PG, Fisher CA, Gaughan J, Santora TA, Pathak AS, Bradley KM, Goldberg AJ. A ten-year retrospective review: does pyloric exclusion improve clinical outcome after penetrating duodenal and combined pancreaticoduodenal injuries? J Trauma. 2007 Apr;62(4):829-33. doi: 10.1097/TA.0b013e318033a790.

    PMID: 17426536BACKGROUND
  • 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.

    PMID: 8371295BACKGROUND
  • Rotondo MF, Zonies DH. The damage control sequence and underlying logic. Surg Clin North Am. 1997 Aug;77(4):761-77. doi: 10.1016/s0039-6109(05)70582-x.

    PMID: 9291979BACKGROUND
  • Moore EE, Burch JM, Franciose RJ, Offner PJ, Biffl WL. Staged physiologic restoration and damage control surgery. World J Surg. 1998 Dec;22(12):1184-90; discussion 1190-1. doi: 10.1007/s002689900542.

    PMID: 9841741BACKGROUND
  • 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.

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
John Mayberry, MD
Organization
Oregon Health & Science University

Study Officials

  • John C Mayberry, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 12, 2013

Results First Posted

August 12, 2013

Record last verified: 2013-05

Locations