May 2024 - Multicenter Trials

May 2024
EAST Monthly Literature Review

"Keeping You Up-to-Date with Current Literature"

Brought to you by the EAST Manuscript and Literature Review Committee

This issue was prepared by EAST Multicenter Trials Committee Members John Tierney, MD, Ryan P. Dumas, MD, FACS and Paul Albini, MD.


Thank you to Haemonetics for supporting the EAST Monthly Literature Review.


In This Issue: Multicenter Trials

Scroll down to see summaries of these articles

Article 1 reviewed by John Tierney, MD
Outcomes among trauma patients with duodenal leak following primary versus complex repair of duodenal injuries: An Eastern Association for the Surgery of Trauma multicenter trial. Choron RL, Teichman AL, et al. J Trauma Acute Care Surg. 2023 Jul 1;95(1):151-159.

Article 2 reviewed by Ryan P. Dumas, MD, FACS
Propensity weighted analysis of chemical venous thromboembolism prophylaxis agents in isolated severe traumatic brain injury: An EAST sponsored multicenter study. Ratnasekera AM, Seng SS, Kim D, et al. Injury. 2024 Apr 9.

Article 3 reviewed by Paul Albini, MD
Outcomes after emergency general surgery and trauma care in incarcerated individuals: An EAST multicenter study. Bryant MK, Tatebe LC, Siva NR, et al. J Trauma Acute Care Surg. 2022 Jul 1;93(1):75-83.
 
 

Article 1
Outcomes among trauma patients with duodenal leak following primary versus complex repair of duodenal injuries: An Eastern Association for the Surgery of Trauma multicenter trial. Choron RL, Teichman AL, et al. J Trauma Acute Care Surg. 2023 Jul 1;95(1):151-159.

Duodenal injury is relatively rare, but is associated with significant potential morbidity, with a post-repair leak rate reported to be up to 33%. In this EAST multicenter trial, the authors sought to compare whether primary duodenal repair alone (PRA) was associated with a lower leak rate than complex duodenal repairs with adjunctive measures (CRAM), which was a heterogenous term they used to encompass repairs such as pyloric exclusion, gastrojejunostomy, retrograde duodenostomy tube with distal feeding access, duodenectomy with anastomosis, pancreatoduodenectomy, or any combination of these techniques. The authors hypothesized that the PRA group wound have a lower leak rate, but that among patients who leaked, CRAM would be associated with improved outcomes.
 
861 patients with duodenal injuries who underwent operative repair and survived at least 24 hours were included. It was a young (33.1 years), predominately male (83.5%), and predominately penetrating-injured (76.8%) population. 523 patients (60.7%) underwent primary repair, and the 338 patients underwent complex repair. Notably, 38.8% of patients who underwent complex repair underwent a combination of the variety of delineated complex procedures. CRAM patients were more likely to have sustained blunt trauma (28.1% vs 20.3%), less likely to sustain stab wounds (12.6% vs 2.1%), had a higher ISS (25 vs 19), higher AIS abdomen, and greater transfusion requirement than PRA patients. They were also less likely to have grade 1 or 2 duodenal injuries; more likely to have ampullary injuries, pancreatic injuries, and pancreatic ductal injuries; and more likely to require a damage-control operation. Overall, 113 patients (15.1%) experienced leak after duodenal repair, including 21% of CRAM patients and 8% of PRA patients. On multivariable analysis, PRA was associated with a decreased risk of duodenal leak (OR 0.42). Among patients who leaked, CRAM was associated with more GI-related complications, longer antibiotic duration, and a longer duration until leak resolution.
 
This study demonstrates that primary repair alone is associated with a lower leak rate than complex repair with adjunctive measures for patients with duodenal injury, but it is a retrospective, observational study that therefore is subject to selection bias, which imposes substantial limitations to its clinical application. Although the authors used a multivariable analysis to attempt to control for the CRAM patients being more severely injured, it is likely that there are factors that contributed to the decision to perform a complex repair that cannot be accounted for in the AAST grading. Secondly, CRAM is a composite variable that refers to a heterogenous group of operations spanning from pyloric exclusion to trauma Whipple, and over a third of the repairs did not fit the authors predefinition of a complex repair. Finally, a primary repair can only be performed when the injury is amenable to primary repair, and the study does not address whether primary repair was technically feasible when complex repair was performed.

Article 2
Propensity weighted analysis of chemical venous thromboembolism prophylaxis agents in isolated severe traumatic brain injury: An EAST sponsored multicenter study. Ratnasekera AM, Seng SS, Kim D, et al. Injury. 2024 Apr 9.

This study collected retrospective chemoprophylaxis data in trauma patients 18 years or older admitted with isolated traumatic brain injury (AIS≥3) who received VTE prophylaxis. The primary outcomes were incidences of VTE and intracranial hemorrhage expansion (ICHE) in two cohorts: patients receiving unfractionated heparin (UH) and those receiving low molecular weight heparin (LMWH). Patients with concomitant injuries were excluded. Additionally, patients with missing outcome variables, patients on pre-injury anticoagulation, and patients who died or were discharged within 48 hours or admission were also excluded. The authors hypothesized that LMWH would not increase VTE and ICHE after VTE prophylaxis (VTEP) initiation compared to UH in patients with severe TBI.
 
984 patients from 24 level 1 and level 2 trauma centers met inclusion criteria. 502 were in the LMWH group and 482 were in the UH group. None of the centers had universal VTE screening protocols. There were no significant differences in LOS, vent days, ICU LOS, disposition, morbidity, or mortality between the two groups after matching. There were no significant differences in VTE amongst the UH and LMWH groups. Patients in the UH group were more likely to receive VTEP both within 24 hours and in 24-48 hours. Most patients either received TID UH or BID LMWH. Almost 60% of patients in both cohorts had VTEP initiated within 48 hours. There was a total of 29(3%) VTE events amongst all the patients receiving VTEP. The 7-day VTE-free estimate was 99% between the two groups. Overall, 284(30 %) of patients had ICHE. ICHE was statistically different between the cohorts, more patients in the UH cohort had ICHE, 165(34%)(UH) vs. 119(23%)(LMWH). After VTEP initiation, however, there were NO significant differences in ICHE. Overall, ICHE occurred within a median of 8.25 hours of admission. Only 3.9% (UH) and 3.4% (LMWH) had ICHE after VTEP initiation. Neurosurgical interventions were similar between the two groups. There were no differences in ICHE after VTEP. Additionally, neurosurgical procedures and mortality were similar between the two groups.
 
Limitations of the study include its retrospective design, inability to account for missed doses, and absence of long-term neurologic outcomes. Additionally, due to the low VTE event-rate, the study is underpowered to detect hypothetical effect sizes between the two cohorts. The authors conclude that were no differences in VTE or ICHE after VTEP initiation, interventions, or mortality between treatment groups.

Article 3
Outcomes after emergency general surgery and trauma care in incarcerated individuals: An EAST multicenter study. Bryant MK, Tatebe LC, Siva NR, et al. J Trauma Acute Care Surg. 2022 Jul 1;93(1):75-83.

This EAST multicenter trial is one of few studies characterizing the outcomes and healthcare disparities in incarcerated surgical patients. Citing the Belmont Report of 1976 that prevents incarcerated patients’ data from being captured in commonly used national surgical databases, this study aimed to elucidate outcomes and needs in two incarcerated populations cared for by acute care surgeons, namely trauma and emergency general surgical patients.
 
12 centers participated in this prospective observational trial. Most hospitals were academically affiliated and 5 held contracts with correctional facilities. Adult incarcerated patients from jail or prison presenting to the ED and evaluated by the acute care surgery team for injury or emergency general surgical diagnoses over a 12-month period between May 2019 and May 2021 were included. The primary outcomes included 90-day readmissions, and 90-day follow-up rates.
 
943 patients were included in the final analysis, with 430 EGS and 513 Trauma patients. Most patients were from jail compared to prison, 80% vs 17%. Overall, most patients, 90% were male. Trauma patients were slightly younger compared to EGS patients. The distribution of race did not vary among the two groups; slightly over half of all patients, 52%, were black and 39% were white. EGS patients had more comorbidities such as obesity, hypertension DM, and CAD. Substance use disorder was similar between groups and common in this population. However psychiatric illness was higher in the trauma compared to EGS patients. The top 3 diagnoses in EGS patients were soft tissue infections, wound infections, and biliary disease. The top 3 diagnoses in trauma patients were head injury, soft tissue injury, and facial fractures.
 
EGS patients had slightly longer median HLOS compared to trauma patients, 4d v 1d. Overall, 8% of patients had in hospital complications; more EGS patients had complications compared to trauma patients, 13% vs. 4%. Mortality was low and similar among groups at 0.9% overall. Prison patients had more complications and readmissions than Jail patients.
 
11% of all patients were readmitted and this was again similar among groups. Multivariable analyses demonstrated that male sex and white race were significantly associated with readmission in EGS patients. Similarly, self-injury and discharge to a non-prison or jail were associated with readmission of trauma patients.
 
29% of all patients made their 90-day follow-up appointments. More EGS compared to trauma patients returned for follow-up, 33% vs 25%. Multivariable analysis for lost to follow-up demonstrated that only having an operation was associated with a decrease in lost to follow-up in EGS patients. In trauma patients, multivariable analysis demonstrated that in addition to having an operation, substance use disorder, and nonwhite race were associated with a decrease in lost to follow-up.
 
This persuasive study makes the case to allow data to be collected in the highly vulnerable population of incarcerated acute care surgery patients to better understand their outcomes in our current healthcare system. This can lead to a better understanding of the resources required not only for in-hospital, but also for post-hospital care, patient education, and injury prevention in these patients.


It's Membership Renewal Time - Sign in to your Profile to check
your renewal status and pay your 2024 dues.




Mark your calendars!
38th EAST Annual Scientific Assembly
January 14-18, 2025
JW Marriott Tucsan Starr Pass Resort & Spa 

Tucson, AZ


 This Literature Review is being brought to you by the EAST Manuscript and Literature Review Committee.
Have a suggestion for a review or an additional comment on articles reviewed?
Please email litreview@east.org.
Previous issues available on the EAST website.