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Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries

Damage Control for Severe Duodenal and Combined Duodenal-Pancreatic Injuries: A Retrospective Review

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00937118
Enrollment
43
Registered
2009-07-10
Start date
2009-07-31
Completion date
2010-11-30
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury of Duodenum, Pancreatic Injury

Keywords

laparotomy, duodenal injury, pancreatic injury, trauma

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.

Interventions

None listed

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Duodenal-related Complications20 yearsDuodenal-related complications including leak, obstruction, and abscess

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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.
41
Total41

Baseline characteristics

CharacteristicInjury Management
Age Continuous34 years
STANDARD_DEVIATION 18
Region of Enrollment
United States
41 participants
Sex: Female, Male
Female
19 Participants
Sex: Female, Male
Male
22 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 41
serious
Total, serious adverse events
0 / 41

Outcome results

Primary

Duodenal-related Complications

Duodenal-related complications including leak, obstruction, and abscess

Time frame: 20 years

Population: Patients with duodenal related complications

ArmMeasureValue (NUMBER)
No Diversion Decompression or ExclusionDuodenal-related Complications13 percentage of subjects
Diversion Decompression or ExclusionDuodenal-related Complications11 percentage of subjects
Damage ControlDuodenal-related Complications8 percentage of subjects
Fascial ClosureDuodenal-related Complications19 percentage of subjects

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026