Optimal Timing for Initiation of Thromboprophylaxis After Hepatic Angioembolization.

OBJECTIVE: To evaluate the optimal timing of thromboprophylaxis (TPX) initiation after hepatic angioembolization in trauma patients. SUMMARY BACKGROUND DATA: TPX after hepatic trauma is complicated by the risk of bleeding, but the relative risk after hepatic angioembolization is unknown. METHODS: Patients who underwent hepatic angioembolization within 24 hours were retrospectively identified from the 2017-19 ACS TQIP datasets. Cases with <24-hour length of stay and other serious injuries were excluded. VTE included DVT and PE. Bleeding complications included hepatic surgery, additional angioembolization, or blood transfusion after TPX initiation. Differences were tested with univariate and multivariate analyses. RESULTS: Of 1,550 patients, 1,370 had initial angioembolization. Bleeding complications were higher in those with TPX initiation within 24 hours (20.0% vs 8.9%, P<0.001) and 48 hours (13.2% vs 8.4%, P=0.013). However, VTE was higher in those with TPX initiation after 48 hours (6.3%vs 3.3%, P=0.025). In the 180 patients with hepatic surgery prior to angioembolization, bleeding complications were higher in those with TPX initiation within 24 hours (72% vs 20%, P <0.001), 48 hours (50% vs 17%, P<0.001), and 72 hours (37% vs 14%, P=0.001). Moreover, DVT was higher in those with TPX initiation after 96 hours (14.3% vs 3.1%, P =0.023). CONCLUSION: This is the first study to address timing of TPX after hepatic angioembolization in a national sample of trauma patients. For these patients, initiation of TPX at 48- 72 hours achieves the safest balance in minimizing bleeding while reducing the risk of VTE. LEVEL OF EVIDENCE: Level III - Retrospective Cohort Study.

Adequate Reporting Among Ventral Hernia Repair Operative Reports: A Cross-Sectional Study of Prevalence of Details and Association With Clinical Outcomes.

Objective: We aimed to evaluate the prevalence of highly detailed ventral hernia repair (VHR) operative reports and associations between operative report detail and postoperative outcomes in a medico-legal dataset. Background: VHR are one of the most common surgical procedures performed in the United States. Previous work has shown that VHR operative reports are poorly detailed, however, the relationship between operative report detail and patient outcomes is unknown. Methods: This is a retrospective cross-sectional observational study. Operative reports describing VHR were obtained from a medical-legal database. Medical records were screened and data was extracted including clinical outcomes, such as surgical site infection (SSI), hernia recurrence, and reoperation and the presence of key details in each report. Highly detailed operative reports were defined as having 70% of recommended details. The primary outcome was the prevalence of highly detailed VHR operative reports. Results: A total of 1011 VHR operative reports dictated by 693 surgeons across 517 facilities in 50 states were included. Median duration of follow-up was 4.6 years after initial surgery. Only 35.7% of operative reports were highly detailed. More recent operative reports, cases with resident involvement, and contaminated procedures were more likely to be highly detailed (all P < 0.05). Compared to poorly detailed operative reports, cases with highly detailed reports had fewer SSIs (13.2% vs 7.5%, P = 0.006), hernia recurrence (65.8% vs 55.4%, P = 0.002), and reoperation (78.9% vs 62.6%, P = 0.001). Conclusions: In this medico-legal dataset, most VHR operative reports are poorly detailed while highly detailed operative reports were associated with lower rates of complications. Future studies should examine a nationally representative dataset to validate our findings.

Early Detection of Ventilator-Associated Pneumonia from Exhaled Breath in ICU Patients.

OBJECTIVES: Evaluate associations between volatile organic compounds (VOCs) in heat and moisture exchange (HME) filters and the presence of ventilator-associated pneumonia (VAP). SUMMARY BACKGROUND DATA: Clinical diagnostic criteria for VAP have poor inter-observer reliability, and cultures are slow to result. Exhaled breath contains VOCs related to Gram-negative bacterial proliferation, the most identified organisms in VAP. We hypothesized that exhaled VOCs on HME filters can predict nascent VAP in mechanically ventilated ICU patients. METHODS: Gas chromatography-mass spectrometry (GC-MS) was used to analyze 111 heat and moisture exchange (HME) filters from 12 intubated patients who developed VAP. Identities and relative amounts of VOCs were associated with dates of clinical suspicion and culture confirmation of VAP. Matched pairs t-tests were performed to compare VOC abundances in HME filters collected within three days pre- and post-clinical suspicion of VAP (pneumonia days), versus outside of these days (non-pneumonia days). A ROC curve was generated to determine the diagnostic potential of VOCs. RESULTS: Carbon disulfide, associated with the proliferation of certain Gram-negative bacteria, was found in samples collected during pneumonia days for 11 of 12 patients. Carbon disulfide levels were significantly greater (P=0.0163) for filters on pneumonia days. The AUROC for carbon disulfide was 0.649 (95%CI 0.419-0.88). CONCLUSIONS: Carbon disulfide associated with Gram-negative VAP can be identified on HME filters up to three days prior to the initial clinical suspicion, and approximately a week prior to culture confirmation. This suggests VOC sensors may have potential as an adjunctive method for early detection of VAP.

A 20-year retrospective analysis of deep venous thrombosis and pulmonary embolism among combat casualties requiring damage-control laparotomy at US military Role 2 surgical units.

BACKGROUND: Combat casualties receiving damage-control laparotomy at forward deployed, resource-constrained US military Role 2 (R2) surgical units require multiple evacuations, but the added risk of venous thromboembolism (VTE) in this population has not been defined. To fill this gap, we retrospectively analyzed 20 years of Department of Defense Trauma Registry data to define the VTE rate in this population. METHODS: Department of Defense Trauma Registry from 2002 to 2023 was queried for US military combat casualties requiring damage-control laparotomy at R2. All deaths were excluded in subsequent analysis. Rates of VTE were assessed, and subgroup analysis was performed on patients requiring massive transfusion. RESULTS: Department of Defense Trauma Registry (n = 288) patients were young (mean age, 25 years) and predominantly male (98%) with severe (mean Injury Severity Score, 26), mostly penetrating injury (76%) and high mortality. Venous thromboembolism rate was high: 15.8% (DVT, 10.3%; pulmonary embolism, 7.1%). In the massively transfused population, the VTE rate was even higher (26.7% vs. 10.2%, p < 0.001). CONCLUSION: This is the first report that combat casualties requiring damage-control laparotomy at R2 have such high VTE rates. Therefore, for military casualties, we propose screening ultrasound upon arrival to each subsequent capable echelon of care and low threshold for initiating thromboprophylaxis. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Initial Hemorrhage Control Procedure for Splenic Injuries May Affect Risk of Venous Thromboembolism.

INTRODUCTION: Venous thromboembolism (VTE) continues to be a major cause of morbidity in trauma. It is unclear whether the type of hemorrhage control procedure (i.e., splenectomy versus angioembolization) is associated with an increased risk of VTE. We hypothesize that hemodynamically stable patients undergoing angioembolization for blunt high-grade splenic injuries have lower rates of VTE compared to those undergoing splenectomy. METHODS: The American College of Surgeons Trauma Quality Program dataset from 2017 to 2019 was queried to identify all patients with American Association for the Surgery of Trauma grade 3-5 blunt splenic injuries. Outcomes including VTE rates were compared between those who were managed with splenectomy versus angioembolization. Propensity score matching (1:1) was performed adjusting for age, sex, initial vital signs, Injury Severity Score, and splenic injury grade. RESULTS: The analysis included 4698 matched patients (splenectomy [n = 2349] and angioembolization [n = 2349]). The median (interquartile range) age was 41 (27-58) years and 69% were male. Patients were well matched between groups. Angioembolization was associated with significantly lower VTE than splenectomy (2.2% versus 3.4%, P = 0.010) despite less use of VTE chemoprophylaxis (70% versus 80%, P < 0.001), as well as a relative delay in initiation of chemoprophylaxis (44 h versus 33 h, P < 0.001). Hospital and intensive care unit length of stay and mortality were also significantly lower in the angioembolization group. CONCLUSIONS: Angioembolization is associated with a significantly lower incidence of VTE than splenectomy. Thus, angioembolization should be considered for initial management of hemodynamically stable patients with high-grade blunt splenic injuries in whom laparotomy is not otherwise indicated.

The Enigma That is Rectal Squamous Cell Carcinoma: A Case Series.

INTRODUCTION: Colorectal cancer is the third most common cancer and the third leading cause of cancer deaths in the United States. As rectal squamous cell carcinoma (SCC) is an uncommon colorectal cancer, there is limited data on this clinical entity. We aimed to evaluate the tumor characteristics, treatment, and clinical outcomes of this rare deadly disease. METHODS: Pathological specimens from 2017 to 2022 at a single National Cancer Institute-designated cancer center were screened for all rectal cases with a diagnosis of SCC. All patients with a primary rectal SCC were included. Patients who had extension to the dentate line or evidence of an anal mass, and those who were treated at an outside institution, were excluded. Demographic, treatment, outcome, and surveillance data was extracted. RESULTS: There were 56 specimens identified, nine of which met inclusion criteria. Most patients were White (78%), Hispanic (78%), and female (67%). The average age at diagnosis was 57 y [52-65]. All patients had nodal involvement at the time of clinical staging. All patients were treated with Nigro protocol, with one patient treated with surgery first. The median time of follow-up was 12 mo after initial treatment, 33% had recurrence, with median time to recurrence of 25 mo. Overall, mortality from rectal SCC was 33% at a median time of 37 mo from initial diagnosis. CONCLUSIONS: Rectal SCC is a colorectal cancer that is not fully understood. Our findings showed that treatment mirrors that of anal SCC, with similar rates of survival to both rectal adenocarcinoma and anal SCC.

Survival of In-Hospital Cardiopulmonary Arrest in Trauma Patients.

INTRODUCTION: Relative to other hospitalized patients, trauma patients are younger with fewer comorbidities, but the incidence and outcomes of in-hospital cardiopulmonary arrest (IHCA) with cardiopulmonary resuscitation (CPR) in this population is unknown. Therefore, we aimed to investigate factors associated with survival in trauma patients after IHCA to test the hypothesis that compared to other hospitalized patients, trauma patients with IHCA have improved survival. METHODS: Retrospective review of the Trauma Quality Improvement Program database 2017 to 2019 for patients who had IHCA with CPR. Primary outcome was survival to hospital discharge. Secondary outcomes were in-hospital complications, hospital length of stay, intensive care unit length of stay, and ventilator days. Data were compared with univariate and multivariate analyses at P < 0.05. RESULTS: In 22,346,677 admitted trauma patients, 14,056 (0.6%) received CPR. Four thousand three hundred seventy-seven (31.1%) survived to discharge versus 26.4% in a national sample of all hospitalized patients (P < 0.001). In trauma patients, median age was 55 y, the majority were male (72.2%). Mortality was higher for females versus males (70.3% versus 68.3%, P = 0.026). Multivariate regression showed that older age 1.01 (95% confidence interval (CI) 1.01-1.02), Hispanic ethnicity 1.21 (95% CI 1.04-1.40), and penetrating trauma 1.51 (95% CI 1.32-1.72) were risk factors for mortality, while White race was a protective factor 0.36 (95% CI 0.14-0.89). CONCLUSIONS: This is the first study to show that the incidence of IHCA with CPR is approximately six in 1000 trauma admissions and 31% survive to hospital discharge, which is higher than other hospitalized patients. Age, gender, racial, and ethnic disparities also influence survival.

Improper Restraint Use in Fatal Pediatric Motor Vehicle Collisions.

PURPOSE: Motor vehicle collisions (MVC) are the second leading cause of death in children and adolescents, but appropriate restraint use remains inadequate. Our previous work shows that about half of pediatric MVC victims presenting to our trauma center were unrestrained. This study evaluates restraint use among children and adolescents who did not survive after MVC. We hypothesize that restraint use is even lower in this population than in pediatric MVC patients who reached our trauma center. METHODS: We reviewed the local Medical Examiner's public records for fatal MVCs involving decedents <19 years old from 2010 to 2021. When restraint use was not documented, local Fire Rescue public records were cross-referenced. Patients were excluded if restraint use was still unknown. Age, demographics, and restraint use were compared using standard statistical methods. RESULTS: Of 199 reviewed cases, 92 met selection criteria. Improper restraint use was documented in 72 patients (78%). Most decedents were White (72% versus 28% Black) and male (74%), with a median age of 17 years [15-18]. Improper restraint use was more common among Black (92% vs 73% White, p = 0.040) and male occupants (85% vs 58% female, p = 0.006). Improper restraint use was lower in the Hispanic population (73%) compared to non-Hispanic individuals (89%), but this difference was not statistically significant (p = 0.090). CONCLUSION: Most pediatric patients who die from MVCs in our county are improperly restrained. While male and Black patients are especially high-risk, the overall dismal rates of restraint use in our pediatric population present an opportunity to improve injury prevention measures. TYPE OF STUDY: Retrospective Comparative Study. LEVEL OF EVIDENCE: Level III.

When is it safe to start thromboprophylaxis after splenic angioembolization?

BACKGROUND: Thromboprophylaxis after blunt splenic trauma is complicated by the risk of bleeding, but the risk after angioembolization is unknown. We hypothesized that earlier thromboprophylaxis initiation was associated with increased bleeding complications without mitigating venous thromboembolism events. METHODS: All blunt trauma patients who underwent splenic angioembolization within 24 hours of arrival were identified from the American College of Surgeons Trauma Quality Improvement Program datasets from 2017 to 2019. Cases with <24-hour length of stay, other serious injuries, and surgery before angioembolization were excluded. Venous thromboembolism was defined as deep vein thrombosis or pulmonary embolism. Bleeding complications were defined as splenic surgery, additional embolization, or blood transfusion after thromboprophylaxis initiation. Data were compared with χ2 analysis and multivariate logistic regression at P < .05. RESULTS: In 1,102 patients, 84% had American Association for the Surgery of Trauma grade III to V splenic injuries, and 73% received thromboprophylaxis. Splenic surgery after angioembolization was more common in those with thromboprophylaxis initiation within the first 24 hours (5.7% vs 1.7%, P = .007), whereas those with the initiation of thromboprophylaxis after 72 hours were more likely to have a pulmonary embolism (2.3% vs 0.2%, P = .001). Overall, venous thromboembolism increased considerably when thromboprophylaxis was initiated after day 3. In multivariate analysis, time to thromboprophylaxis initiation was associated with bleeding (odds ratio 0.74 [95% confidence interval 0.58-0.94]) and venous thromboembolism complications (odds ratio 1.5 [95% confidence interval 1.20-1.81]). CONCLUSION: This national study evaluates bleeding and thromboembolic risk to elucidate the specific timing of thromboprophylaxis after splenic angioembolization. Initiation of thromboprophylaxis between 24 and 72 hours achieves the safest balance in minimizing bleeding and venous thromboembolism risk, with 48 hours particularly serving as the ideal time for protocolized administration.

Management of lower extremity vascular injuries in pediatric trauma patients: 20-year experience at a level 1 trauma center.

Introduction: Pediatric lower extremity vascular injuries (LEVI) are rare but can result in significant morbidity. We aimed to describe our experience with these injuries, including associated injury patterns, diagnostic and therapeutic challenges, and outcomes. Methods: This was a retrospective review at a single level 1 trauma center from January 2000 to December 2019. Patients less than 18 years of age with LEVI were included. Demographics, injury patterns, clinical status at presentation, and intensive care unit (ICU) and hospital length of stay (LOS) were collected. Surgical data were extracted from patient charts. Results: 4,929 pediatric trauma patients presented during the 20-year period, of which 53 patients (1.1%) sustained LEVI. The mean age of patients was 15 years (range 1-17 years), the majority were Black (68%), male (96%), and most injuries were from a gunshot wound (62%). The median Glasgow Coma Scale score was 15, and the median Injury Severity Score was 12. The most commonly injured arteries were the superficial femoral artery (28%) and popliteal artery (28%). Hard signs of vascular injury were observed in 72% of patients and 87% required operative exploration. There were 36 arterial injuries, 36% of which were repaired with a reverse saphenous vein graft and 36% were repaired with polytetrafluoroethylene graft. One patient required amputation. Median ICU LOS was three days and median hospital LOS was 15 days. There were four mortalities. Conclusion: Pediatric LEVIs are rare and can result in significant morbidity. Surgical principles for pediatric vascular injuries are similar to those applied to adults, and this subset of patients can be safely managed in a tertiary specialized center. Level of evidence: Level IV, retrospective study.

Immediate Versus Delayed Surgical Management of Infant Cryptorchidism With Inguinal Hernia.

INTRODUCTION: Cryptorchidism is commonly treated with orchiopexy at 6-12 months of age, often allowing time for undescended testicle(s) (UT) to descend spontaneously. However, when an inguinal hernia (IH) is also present, some surgeons perform orchiopexy and inguinal hernia repair (IHR) immediately rather than delaying surgery. We hypothesize that early surgical intervention provides no benefit for newborns with both IH and UT. METHODS: The Nationwide Readmissions Database was used to identify newborns with diagnoses of both IH and UT from 2010 to 2014. Patients were stratified by management: IHR performed on initial admission (Repair) or not (Deferral). Demographics, outcomes, and complications were compared. Results were weighted for national estimates. RESULTS: We analyzed 1306 newborns (64% premature) diagnosed with both IH and UT. IHR was performed at index admission in 30%. Repair was more common in premature babies (43% vs. 8% full-term, p < 0.001) and patients with congenital anomalies (33% vs. 27% without congenital anomaly, p = 0.012). There was no difference in readmission rates. Repair patients had higher rates of orchiectomy than did Deferral. No Deferral patients were readmitted for bowel resection, and <1% were readmitted for orchiectomy or hernia incarceration. CONCLUSION: In newborns with UT and IH, immediate repair is not associated with improved outcomes. Even with incarceration on initial presentation, rates of readmission with incarceration or bowel compromise for patients who undergo Deferral of surgery are minimal. Moreover, Repair newborns have higher rates of orchiectomy. We found no benefit to early operative intervention; thus, we recommend waiting until 6-12 months of age to reassess for surgery. LEVEL OF EVIDENCE: Level III TYPE OF STUDY: Retrospective Comparative Study.

Admission to a Verified Pediatric Trauma Center is Associated With Improved Outcomes in Severely Injured Children.

BACKGROUND: Previous studies have shown improved survival for severely injured adult patients treated at American College of Surgeons verified level I/II trauma centers compared to level III and undesignated centers. However, this relationship has not been well established in pediatric trauma centers (PTCs). We hypothesize that severely injured children will have lower mortality at verified level I/II PTCs compared to centers without PTC verification. METHODS: All patients 1-15 years of age with ISS >15 in the 2017-2019 American College of Surgeons Trauma Quality Programs (ACS TQP) dataset were reviewed. Patients with pre-hospital cardiac arrest, burns, and those transferred out for ongoing inpatient care were excluded. Logistic regression models were used to assess the effects of pediatric trauma center verification on mortality. RESULTS: 16,301 patients were identified (64 % male, median ISS 21 [17-27]), and 60 % were admitted to verified PTCs. Overall mortality was 6.0 %. Mortality at centers with PTC verification was 5.1 % versus 7.3 % at centers without PTC verification (p < 0.001). After controlling for injury mechanism, sex, age, pediatric-adjusted shock index (SIPA), ISS, arrival via interhospital transfer, and adult trauma center verification, pediatric level I/II trauma center designation was independently associated with decreased mortality (OR 0.72, 95 % CI 0.61-0.85). CONCLUSIONS: Treatment at ACS-verified pediatric trauma centers is associated with improved survival in critically injured children. These findings highlight the importance of PTC verification in optimizing outcomes for severely injured pediatric patients and should influence trauma center apportionment and prehospital triage. LEVEL OF EVIDENCE: Level IV - Retrospective review of national database.

Timing of Pediatric Incarcerated Inguinal Hernia Repair: A Review of Nationwide Readmissions Data.

INTRODUCTION: In pediatric patients, incarcerated inguinal hernias are often repaired on presentation. We hypothesize that in appropriate patients, repair may be safely deferred. METHODS: The Nationwide Readmissions Database was used to identify pediatric patients (aged < 18 y) with incarcerated inguinal hernia from 2010 to 2014. Patients were stratified by management approach (Early Repair versus Deferral). Overall frequencies of these operative strategies were calculated. Propensity score matching was then performed to control for patient age, comorbidities, perinatal conditions, and congenital anomalies. Outcomes including complications, surgical procedures, and readmissions were compared. Outpatient surgeries were not assessed. RESULTS: Among 6148 total patients with incarcerated inguinal hernia, the most common strategy was to perform Early Repair (88% versus 12% Deferral). Following propensity score matching, the cohort included 1288 patients (86% male, average age 1.7 ± 4.1 years). Deferral was associated with equivalent rates of readmission within one year (13% versus 15%, P = 0.143), but higher readmissions within the first 30 days (7% versus 3%, P = 0.002) than Early Repair. Deferral patients had lower rates of orchiectomy (2% versus 5%, P = 0.001), wound infections (< 2% versus 2%, P = 0.020), and other infections (7% versus 15%, P < 0.001). The frequency of other complications including bowel resection, oophorectomy, testicular atrophy, sepsis, and pneumonia were equivalent between groups. Three percent of Deferrals had a diagnosis of incarceration on readmission. CONCLUSIONS: Deferral of incarcerated inguinal hernia repair at index admission is associated with higher rates of hospital readmissions within the first 30 days but equivalent readmission within the entire calendar year. These patients are at risk of repeat incarceration but have significantly lower rates of orchiectomy than their counterparts who undergo inguinal hernia repair at the index admission. We propose that prospective studies be performed to identify good candidates for Elective Deferral following manual reduction and overnight observation. Such studies must capture outpatient surgical outcomes.

Nationwide Analysis of Firearm Injury Versus Other Penetrating Trauma: It's Not All the Same Caliber.

INTRODUCTION: Ballistic injuries cause both a temporary and permanent cavitation event, making them far more destructive and complex than other penetrating trauma. We hypothesized that global injury scoring and physiologic parameters would fail to capture the lethality of gunshot wounds (GSW) compared to other penetrating mechanisms. METHODS: The 2019 American College of Surgeons Trauma Quality Programs participant use file was queried for the mortality rate for GSW and other penetrating mechanisms. A binomial logistic regression model ascertained the effects of sex, age, hypotension, tachycardia, mechanism, Glasgow Coma Scale, ISS, and volume of blood transfusion on the likelihood of mortality. Subgroup analyses examined isolated injuries by body regions. RESULTS: Among 95,458 cases (82% male), GSW comprised 46.4% of penetrating traumas. GSW was associated with longer hospital length of stay (4 [2-9] versus 3 [2-5] days), longer intensive care unit length of stay (3 [2-6] versus 2 [2-4] days), and more ventilator days (2 [1-4] versus 2 [1-3]) compared to stab wounds, all P < 0.001. The model determined that GSW was linked to increased odds of mortality compared to stab wounds (odds ratio 4.19, 95% confidence interval 3.55-4.93). GSW was an independent risk factor for acute kidney injury, acute respiratory distress syndrome, venous thromboembolism, sepsis, and surgical site infection. CONCLUSIONS: Injury scoring systems based on anatomical or physiological derangements fail to capture the lethality of GSW compared to other mechanisms of penetrating injury. Adjustments in risk stratification and reporting are necessary to reflect the proportion of GSW seen at each trauma center. Improved classification may help providers develop quality processes of care. This information may also help shape public discourse on this highly lethal mechanism.

Fascial Defect Closure During Ventral Hernia Repair: A Systematic Review of Randomized Controlled Trials.

Background: During minimally invasive ventral hernia repair (VHR) it is unknown if a fascial defect closure, as opposed to a bridged repair (current care), is beneficial for patients. We sought to systematically review the published literature on the role of fascial defect closure during minimally invasive VHR. Methods: PubMed, Embase, Scopus, Cochrane, and Clinicaltrials.gov were reviewed for randomized controlled trials (RCTs) that compared fascial defect closure with bridged repair. The primary outcome was major complications defined as deep/organ-space surgical site infections (SSIs), reoperations, hernia recurrences, or deaths. Secondary outcomes included SSI, seroma, eventration, hernia recurrence, post-operative pain, and quality of life (QOL). Pooled risk ratios with 95% confidence intervals were obtained through random effect meta-analyses. Results: Of 579 screened articles, 6 publications of 5 RCTs were included. No significant difference in major complications (10.6% vs 10.4%, RR=1.05, 95% CI=0.51-2.14, P=.90) or recurrences (9.0% vs 10.6%, RR=0.92, 95% CI=0.32-2.61, P=.87) were found between groups. Fascial defect closure decreased the risk of seromas (22.9% vs 34.2%, RR=0.60, 95% CI=0.37-0.97, P=.04) and may decrease the risk of eventrations (6.7% vs 9.0%, RR=0.74, 95% CI=0.37-1.50, P=.41) at the expense of potentially increasing the risk of SSI (3.2% vs 1.4%, RR=1.89, 95% CI=0.60-5.93; P=.28). Reporting of pain and QOL scores was inconsistent. Conclusion: While most individual RCTs demonstrated benefit with fascial defect closure during minimally invasive VHR, our meta-analysis of fascial defect closure demonstrated only a statistically significant difference in seromas compared to bridged repair. Large, multi-center RCTs are needed.

Mesh Type With Ventral Hernia Repair: A Systematic Review and Meta-analysis of Randomized Trials.

INTRODUCTION: Synthetic mesh is widely utilized for clean ventral hernia repair; however, it is unclear if synthetic mesh provides the same benefits with high-risk patients or during contaminated cases. Many surgeons use biologic mesh in these settings, but there is little evidence to support this practice. Our objective was to compare the clinical outcomes of utilizing biologic mesh versus synthetic mesh during ventral hernia repair. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, a review of the literature was conducted using Cochrane library, EMBASE, Clinicaltrials.gov, and PubMed for randomized controlled trials published that compared biologic versus synthetic mesh during ventral hernia repair. The primary outcome was major complications defined as deep or organ space surgical site infection, reoperations, and hernia recurrences. RESULTS: Of 1889 manuscripts screened, four publications were included. The four studies included a total of 758 patients, with 381 receiving biologic mesh and 377 receiving synthetic mesh. Compared to biologic mesh, synthetic mesh had lower rates of major complications (38.6% versus 23.4, risk ratio = 0.55, 95% confidence interval = 0.35 to 0.86, P = 0.009) and hernia recurrence (24.5 % versus 10.3%, risk ratio = 0.44, 95% confidence interval = 0.28 to 0.69, P = 0.004). In addition, there was a lower percentage of surgical site infection and reoperation in the synthetic mesh group. CONCLUSIONS: Contrary to current surgical teaching, placement of permanent synthetic mesh into a contaminated field yielded rates of complications that were comparable or reduced compared to biologic mesh.

Hernia Prevention Using Biologic Mesh and/or Small Bites: A Multispecialty 2 × 2 Factorial Randomized Controlled Trial.

BACKGROUND: Ventral incisional hernias are the most common complication after abdominal operation. Randomized trials have shown efficacy of prophylactic synthetic mesh and small bites. Adoption of these practices has been limited due to concerns with placement of synthetic mesh in contaminated cases and small bites in an overweight population. We sought to assess the efficacy of prophylactic biologic mesh and small bites to prevent postoperative major complications: ventral incisional hernias, surgical site infection, reoperation, and death. STUDY DESIGN: High-risk patients (overweight/obese, current smoker) undergoing abdominal operation with a midline incision (5 cm or greater) were randomized (2 × 2 factorial trial) to receive either sublay biologic mesh or no mesh and either small bites (0.5 × 0. 5cm) or large bites (1 × 1 cm) fascial closure. The primary outcome measure was major complications at 1 year postoperative. CONSORT guidelines were followed, and this study was registered on clinicaltrials.gov (NCT03148496). Assuming α = 0.05, ß = 0.20, and Δ = 20%, it was estimated that 105 patients were needed. Primary outcome was assessed using Fisher's exact test. RESULTS: A total of 107 patients were randomized: 52 (49%) to mesh, 55 (51%) to no mesh, 55 (51%) to small bites, and 52 (49%) to large bites. Of the patients, 16% were smokers, 31% were overweight, and 55% were obese. At 1 year postoperative, there were no differences in major complications between groups (mesh vs no mesh 21% vs 16%, p = 0.62; small vs large bites 18% vs 19%, p = 1.00). CONCLUSIONS: In this trial, biologic mesh and small bites appear to have no benefit. Further randomized trials are needed among high-risk patients before widespread adoption of prophylactic biologic mesh or small bites.

Statistical Power of Randomized Controlled Trials in Trauma Surgery.

BACKGROUND: Our purpose was to conduct a bibliometric study investigating the prevalence of underpowered randomized controlled trials (RCTs) in trauma surgery. STUDY DESIGN: A medical librarian conducted a search of RCTs in trauma published from 2000 to 2021. Data extracted included study type, sample size calculation, and power analyses. Post hoc calculations were performed using a power of 80% and an alpha level of 0.05. A CONSORT checklist was then tabulated from each study as well as a fragility index for studies with statistical significance. RESULTS: In total 187 RCTs from multiple continents and 60 journals were examined. A total of 133 (71%) were found to have "positive" findings consistent with their hypothesis. When evaluating their methods, 51.3% of articles did not report how they calculated their intended sample size. Of those that did, 25 (27%) did not meet their target enrollment. When examining post hoc power, 46%, 57%, and 65% were adequately powered to detect small, medium, and large effect sizes, respectively. Only 11% of RCTs had complete adherence with CONSORT reporting guidelines and the average CONSORT score was 19 out of 25. For positive superiority trials with binary outcomes, the fragility index median (interquartile range) was 2 (2 to 8). CONCLUSIONS: A concerningly large proportion of recently published RCTs in trauma surgery do not report a priori sample size calculations, do not meet enrollment targets, and are not adequately powered to detect even large effect sizes. There exists opportunity for improvement of trauma surgery study design, conduct, and reporting.