Trial Outcomes & Findings for Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries (NCT NCT00937118)
NCT ID: NCT00937118
Last Updated: 2013-08-12
Results Overview
Duodenal-related complications including leak, obstruction, and abscess
Recruitment status
COMPLETED
Target enrollment
43 participants
Primary outcome timeframe
20 years
Results posted on
2013-08-12
Participant Flow
Inpatients requiring laparotomy for trauma with duodenal injury years 1989 - 2009
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries
Baseline characteristics by cohort
| Measure |
Injury Management
n=41 Participants
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.
|
|---|---|
|
Age Continuous
|
34 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 yearsPopulation: Patients with duodenal related complications
Duodenal-related complications including leak, obstruction, and abscess
Outcome measures
| Measure |
No Diversion Decompression or Exclusion
n=23 Participants
Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques
|
Diversion Decompression or Exclusion
n=18 Participants
Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques
|
Damage Control
n=25 Participants
Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique
|
Fascial Closure
n=16 Participants
Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
|
|---|---|---|---|---|
|
Duodenal-related Complications
|
13 percentage of subjects
|
11 percentage of subjects
|
8 percentage of subjects
|
19 percentage of subjects
|
Adverse Events
Injury Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place