Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00937118
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Injury of Duodenum; Pancreatic Injury

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Damage Control for Severe Duodenal and Combined Duodenal-Pancreatic Injuries: A Retrospective Review
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Duodenal-related Complications [20 years]

   Duodenal-related complications including leak, obstruction, and abscess

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kashuk JL, Moore EE, Cogbill TH. Management of the intermediate severity duodenal injury. Surgery. 1982 Oct;92(4):758-64.
• 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.
• Rickard MJ, Brohi K, Bautz PC. Pancreatic and duodenal injuries: keep it simple. ANZ J Surg. 2005 Jul;75(7):581-6.
• 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.
• Rotondo MF, Zonies DH. The damage control sequence and underlying logic. Surg Clin North Am. 1997 Aug;77(4):761-77. Review.
• 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.
• 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.
• Stone HH, Fabian TC. Management of duodenal wounds. J Trauma. 1979 May;19(5):334-9.
• Talving P, Nicol AJ, Navsaria PH. Civilian duodenal gunshot wounds: surgical management made simpler. World J Surg. 2006 Apr;30(4):488-94.

• Responsible Party: John C. Mayberry, Professor of Surgery, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00937118
• Other Study ID Numbers: IRB # 5128
• First Posted: Jul 10, 2009
• Last Update Posted: Aug 12, 2013
• Last Verified: May 1, 2013

• Keywords provided by John C. Mayberry, Professor of Surgery, Oregon Health and Science University: laparotomy; duodenal injury; pancreatic injury; trauma
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Recruitment Details	Inpatients requiring laparotomy for trauma with duodenal injury years 1989 - 2009

Arm/Group Title	Injury Management
Arm/Group Description	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.
Period Title: Overall Study
STARTED	41
COMPLETED	41
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Injury Management
Arm/Group Description	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.
Overall Participants	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (18)
Sex: Female, Male (Count of Participants)
Female	19 46.3%
Male	22 53.7%
Region of Enrollment (participants) [Number]
United States	41 100%

Outcome Measures

1. Primary Outcome

Title	Duodenal-related Complications
Description	Duodenal-related complications including leak, obstruction, and abscess
Time Frame	20 years

Outcome Measure Data

Analysis Population Description

Patients with duodenal related complications

Arm/Group Title	No Diversion Decompression or Exclusion	Diversion Decompression or Exclusion	Damage Control	Fascial Closure
Arm/Group Description	Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques	Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques	Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique	Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
Measure Participants	23	18	25	16
Number [percentage of subjects]	13	11	8	19

Adverse Events

Arm/Group Title	Injury Management
Arm/Group Description	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.
All Cause Mortality
	Injury Management
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Injury Management
	Affected / at Risk (%)	# Events
Total	0/41 (0%)
Other (Not Including Serious) Adverse Events
	Injury Management
	Affected / at Risk (%)	# Events
Total	0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.