A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

A Stitch in Time Saves Clots: Venous Thromboembolism Chemoprophylaxis in Traumatic Brain Injury.

BACKGROUND: Venous thromboembolism chemoprophylaxis (VTE-CHEMO) is often delayed in patients with traumatic brain injury because of the concern for intracranial hemorrhage (ICH) progression. We hypothesize that (1) late time to VTE-CHEMO (≥48 h) is associated with higher incidence of VTE, and (2) VTE-CHEMO use does not correlate with ICH progression. MATERIALS AND METHODS: This is a multiinstitutional retrospective study of patients with traumatic brain injury admitted between 2014 and 2016. Inclusion criteria were head Abbreviated Injury Code ≥2, ICH present on initial head computed tomography, and two or more head computed tomography scans after admission. The primary outcome was VTE, and the secondary outcome was ICH progression. Patients were classified as receiving VTE-CHEMO early (<48 h) or late (≥48 h). Multivariable analysis with Cox proportional hazards regression was performed. RESULTS: Overall, 1803 patients were included. Patients with VTE (n = 137) were more likely to have spinal cord injury, blunt cerebrovascular injury, pelvic or femur fractures, and missed VTE-CHEMO doses. After multivariable regression, body mass index >30 (hazard ratio [HR], 1.05; P = 0.002), Injury Severity Score (HR, 1.004; P < 0.001), pelvic or femur fractures (HR, 1.05; P < 0.0001), spinal cord injury (HR, 1.28; P = 0.02), and missed VTE-CHEMO doses (HR, 1.08; P = 0.01) were significant predictors of VTE. In those who required neurosurgery, late VTE-CHEMO predicted VTE (HR, 1.21; P = 0.0001). Overall, 32% patients experienced ICH progression, which did not correlate with VTE-CHEMO use or timing. CONCLUSIONS: This multicenter study highlights benefits from early VTE-CHEMO and identifies high-risk groups who may benefit from more aggressive prophylaxis. These data also emphasize risk to patients by withholding VTE-CHEMO.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.

Importance: In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs. Objective: To assess the use and safety of outpatient management of acute appendicitis. Design, Setting, and Participants: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020. Exposures: Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively. Main Outcomes and Measures: Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared. Results: Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores. Conclusions and Relevance: These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.

IMPORTANCE: Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making. OBJECTIVE: To assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021. EXPOSURES: Appendectomy vs antibiotics. MAIN OUTCOMES AND MEASURES: Conditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons. RESULTS: Of 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91). CONCLUSIONS AND RELEVANCE: This cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.

Endovascular repair compared with operative repair of traumatic rupture of the thoracic aorta: a nonsystematic review and a plea for trauma-specific reporting guidelines.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become the preferred intervention for managing traumatic thoracic aortic injury. The literature suggests that TEVAR is associated with reduced mortality and paraplegia compared with open repair (OR). The lack of guidelines for reporting results and the paucity of patient follow-up make interpretation of the literature difficult. METHODS: A literature review of English language papers on thoracic aortic trauma published between 2005 and 2010 was performed. Papers were analyzed to determine how many commented on injury data known to affect outcome (age, hemodynamic stability, injury severity, degree of aortic injury, etc.). RESULTS: Sixty-two retrospective reviews and six meta-analysis papers were identified. Of the review papers, only 6.4% described aortic anatomy using standard criteria, only 25.8% reported the degree of aortic injury, only 19.4% defined early or emergent intervention, only 32.3% provided details regarding hemodynamic stability, and only 56.5% described injury severity by Injury Severity Score. In a subset analysis of papers containing trauma relevant data, comparing TEVAR with OR, the TEVAR population was older, whereas the OR group was more often unstable. TEVAR had a significantly lower mortality, a trend to reduction in paralysis, but a significantly increased stroke rate. Follow-up was minimal in both groups. CONCLUSION: The lack of reporting guidelines coupled with a paucity of follow-up data weakens any recommendation regarding the optimal choice of intervention. To address these deficiencies, we recommend reporting guidelines specific to the trauma population that will allow better risk adjustment and improve the quality of the evidence base.

The Pathophysiology and Management of Hemorrhagic Shock in the Polytrauma Patient.

The recognition and management of life-threatening hemorrhage in the polytrauma patient poses several challenges to prehospital rescue personnel and hospital providers. First, identification of acute blood loss and the magnitude of lost volume after torso injury may not be readily apparent in the field. Because of the expression of highly effective physiological mechanisms that compensate for a sudden decrease in circulatory volume, a polytrauma patient with a significant blood loss may appear normal during examination by first responders. Consequently, for every polytrauma victim with a significant mechanism of injury we assume substantial blood loss has occurred and life-threatening hemorrhage is progressing until we can prove the contrary. Second, a decision to begin damage control resuscitation (DCR), a costly, highly complex, and potentially dangerous intervention must often be reached with little time and without sufficient clinical information about the intended recipient. Whether to begin DCR in the prehospital phase remains controversial. Furthermore, DCR executed imperfectly has the potential to worsen serious derangements including acidosis, coagulopathy, and profound homeostatic imbalances that DCR is designed to correct. Additionally, transfusion of large amounts of homologous blood during DCR potentially disrupts immune and inflammatory systems, which may induce severe systemic autoinflammatory disease in the aftermath of DCR. Third, controversy remains over the composition of components that are transfused during DCR. For practical reasons, unmatched liquid plasma or freeze-dried plasma is transfused now more commonly than ABO-matched fresh frozen plasma. Low-titer type O whole blood may prove safer than red cell components, although maintaining an inventory of whole blood for possible massive transfusion during DCR creates significant challenges for blood banks. Lastly, as the primary principle of management of life-threatening hemorrhage is surgical or angiographic control of bleeding, DCR must not eclipse these definitive interventions.

Cecal Volvulus as a Rare Complication of Osimertinib Dosed at 160 mg in Patients With EGFR-Mutant Non-small Cell Lung Cancer.

Background: Osimertinib is a 3rd-generation tyrosine kinase inhibitor (TKI) that blocks the epidermal growth factor receptor (EGFR) in non-small lung cancer (NSCLC) and has dramatically improved outcomes for patients with EGFR mutations. While gastrointestinal complications such as diarrhea have been reported with EGFR inhibitors (due to off-target interactions with EGFR receptors within the gut lining), cecal volvulus is an extremely rare complication in advanced malignancy. To date, there are no reported cases associating cecal volvulus with any EGFR TKIs. Case Presentation: In this case series, we present three cases of cecal volvulus among patients with EGFR-positive NSCLC patients treated with osimertinib dosed at double the standard 80 mg dose (160 mg daily). No patient was receiving concurrent chemotherapy or bevacizumab at the time of this described complication. In two cases where pathology was available for review, peritoneal carcinomatosis or intra-abdominal spread was not observed. In a retrospective evaluation of 101 patients treated with osimertinib in our institution, there was a statistically significant difference in the incidence of cecal volvulus among patients receiving osimertinib at 160 mg vs. patients receiving the 80 mg dose (27 vs. 0%; p < 0.001). Conclusions: To our knowledge, these are the first cases to highlight a potentially important and serious gastrointestinal complication associated with the 160 mg dose of osimertinib.

Effect of Pre-Hospital Use of the Assessment of Blood Consumption Score and Pre-Thawed Fresh Frozen Plasma on Resuscitation and Trauma Mortality.

BACKGROUND: Early blood product resuscitation reduces trauma patient mortality from hemorrhage. This mortality benefit depends on a system that can rapidly identify actively bleeding patients, initiate massive transfusion protocol (MTP), and mobilize resources to the bedside. We hypothesized that process improvement efforts that identify patients early and mobilize appropriate blood products to the bedside for immediate use would improve mortality. STUDY DESIGN: Pre-implementation, MTP activation was at the discretion of the trauma surgeon, and only PRBCs were immediately available. In June 2016, the Assessment of Blood Consumption (ABC) score was incorporated in our pre-hospital triage process, and a process for thawed plasma to be available was developed. We performed a retrospective review of patients who were hypotensive on arrival or had MTP activated. We compared mortality and MTP component ratios 15 months pre- vs 15 months post-implementation. RESULTS: Activations of MTP increased 6-fold, while the specificity of the process remained the same. In patients receiving MTP, appropriate blood product transfusion ratios increased 44%. Overall and penetrating trauma mortality improved by 23% and 41%, respectively. When divided by the Injury Severity Score (ISS), penetrating trauma mortality decreased by 65% for the ISS subgroup 15 to 24 and by 38% for ISS subgroup ≥ 25. Length of stay, ICU length of stay, and readmission rates were not significantly different. CONCLUSIONS: Delivery of balanced blood product resuscitation is essential to confer mortality benefits. Process improvement directed at early recognition of the hemorrhagic patient, immediate product availability, and product delivery to the bedside for transfusion allows for mortality reduction without increased resource use.

End-tidal carbon dioxide underestimates plasma carbon dioxide during emergent trauma laparotomy leading to hypoventilation and misguided resuscitation: A Western Trauma Association Multicenter Study.

BACKGROUND: End-tidal carbon dioxide (ETCO2) is routinely used during elective surgery to monitor ventilation. The role of ETCO2 monitoring in emergent trauma operations is poorly understood. We hypothesized that ETCO2 values underestimate plasma carbon dioxide (pCO2) values during resuscitation for hemorrhagic shock. METHODS: Multicenter trial was performed analyzing the correlation between ETCO2 and pCO2 levels. RESULTS: Two hundred fifty-six patients resulted in 587 matched pairs of ETCO2 and pCO2. Correlation between these two values was very poor with an R of 0.04. 40.2% of patients presented to the operating room acidotic and hypercarbic with a pH less than 7.30 and a pCO2 greater than 45 mm Hg. Correlation was worse in patients that were either acidotic or hypercarbic. Forty-five percent of patients have a difference greater than 10 mm Hg between ETCO2 and pCO2. A pH less than 7.30 was predictive of an ETCO2 to pCO2 difference greater than 10 mm Hg. A difference greater than 10 mm Hg was predictive of mortality independent of confounders. CONCLUSION: Nearly one half (45%) of patients were found to have an ETCO2 level greater than 10 mm Hg discordant from their PCO2 level. Reliance on the discordant values may have contributed to the 40% of patients in the operating room that were both acidotic and hypercarbic. Early blood gas analysis is warranted, and a lower early goal of ETCO2 should be considered. LEVEL OF EVIDENCE: Therapeutic, level IV.

Outcomes of Recreational Activity-Associated Trauma in Elderly Persons on Blood-Thinning Medications.

With increasing life expectancy, the elderly are participating in recreational activities traditionally pursued by younger persons. Elderly patients have many reasons for worse outcomes after trauma, one of which may be the rising use of anticoagulant and/or antiplatelet medications. This study aimed to determine whether preinjury use of these agents yielded worse outcomes in geriatric patients injured during high-impact recreational activities. The National Trauma Data Bank was reviewed from 2007 to 2010 for patients ≥65 years admitted to Level I or II trauma centers with ICD-9 E-codes for specific mechanisms of injury. These included motorcycles, bicycles, snowmobiles, all-terrain vehicles, equestrian, water and alpine skiing, snowboarding, and others. Patients with preinjury bleeding disorder (BD), including warfarin and clopidogrel use, were compared with controls via a coarsened exact matching analysis. BD patients (294) were compared with 3929 controls. Although increased in BD patients, no significant mortality differences were observed in unmatched or matched analyses. BD patients yielded greater hospital length of stay (5 vs 4 days, P = 0.020) with increased odds of receiving five units or more of blood (7.0% vs 2.1%, odds ratio = 4.7, P < 0.001) and of deep vein thrombosis (7.6% vs 3.8%, odds ratio = 2.1, P = 0.018). Elderly patients with BD, including warfarin or clopidogrel use, do not seem to have significantly increased mortality after injury during specified recreational activities. BD patients had greater hospital length of stay, transfusion requirements, and deep vein thrombosis rates. These findings may inform counseling for those taking such medications as to the potential for adverse outcomes.

The evolution of care improves outcome in blunt thoracic aortic injury: A Western Trauma Association multicenter study.

BACKGROUND: The management of blunt thoracic aortic injury (BTAI) has evolved radically in the last decade with changes in the processes of care and the introduction of thoracic endovascular aortic repair (TEVAR). These changes have wrought improved outcome, but the direct effect of TEVAR on outcome remains in question as previous studies have lacked vigorous risk adjustment and long-term follow-up. To address these knowledge gaps, we compared the outcomes of TEVAR, open surgical repair, and nonoperative management for BTAI. METHODS: Eight verified trauma centers recruited from the Western Trauma Association Multicenter Study Group retrospectively studied all patients with BTAI admitted between January 1, 2006, and June 30, 2016. Data included demographics, comorbidities, admitting physiology, injury severity, in-hospital care, and outcome. RESULTS: We studied 316 patients with BTAI; 57 (18.0%) were in extremis and died before treatment. Of the 259 treated surgically, TEVAR was performed in 176 (68.0%), open in 28 (10.8%), hybrid in 4 (1.5%), and nonoperative in 51 (19.7%). Thoracic endovascular aortic repair and open repair groups had similar Injury Severity Scale score, chest Abbreviated Injury Scale score, Trauma and Injury Severity Score, and probability of survival, but differed in median age (open: 28 [interquartile range {IQR}, 19-51]; TEVAR: 46 [IQR, 28-60]; p < 0.007), zone of aortic injury (p < 0.001), and grade of aortic injury (open: 6 [IQR, 4-6]; TEVAR: 2 [IQR, 2-4]; p < 0.001). The overall in-hospital mortality was 6.6% (TEVAR: 5.7%, open: 10.7%, nonoperative: 3.9%; p = 0.535). Of the 240 patients who survived to discharge, two died (one at 9 months and one at 8 years); both were managed with TEVAR, but the deaths were unrelated to the aortic procedure. Stent graft surveillance computed tomography scans were not obtained in 37.6%. CONCLUSIONS: The mortality of BTAI continues to decrease. Thoracic endovascular aortic repair, when anatomically suitable, should be the treatment of choice. Open repair remains necessary for more proximal injuries. Process improvement in computed tomography imaging in follow-up of TEVAR is warranted. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

National Outcomes after Pressure Ulcer Closure: Inspiring Surgery.

Over two million Americans receive treatment for pressure ulcers (PUs) annually, but national surgical outcomes are not well described. This study investigated rates and risk factors of postoperative complications in patients with PU. The 2011 and 2012 American College of Surgeons-National Surgical Quality Improvement Project database was queried and PU patients undergoing flap closure were identified. Descriptive statistics and multivariate regression analysis was used and reported as odds ratios (ORs) if (P < 0.05). Of 1196 patients identified with a primary diagnosis of PU, 327 (27%) underwent flap closure. Emergency interventions were performed in seven patients who were excluded from analysis. Characteristics were average age 53.3 (±17); 65 per cent male; 41 per cent with grossly contaminated or infected wounds; 29 per cent frail; and 16 per cent with an American Society of Anesthesiologists score of four or five. Myocutaneous or fasciocutaneous flaps were performed in 82 per cent of patients, local skin rearrangements in 17 per cent, and free flap in one patient. Complications were low with 1.9 per cent recurrence and 4.7 per cent reoperation rates. Higher American Society of Anesthesiologists was independently associated with mortality (odds ratio = 6.6) and steroid use correlated with flap failure (odds ratio = 15). No differences in complication profiles were identified based on technique, frailty, or contamination. Surgical closure can be considered reasonable in all patients fit for anesthesia.

Prophylactic Fresh Frozen Plasma Infusion is Ineffective in Reversing Warfarin Anticoagulation and Preventing Delayed Intracranial Hemorrhage After Falls.

BACKGROUND: Elderly patients, with considerable fall risk, are increasingly anticoagulated to prevent thromboembolic disease. We hypothesized that a policy of prophylactic fresh frozen plasma (FFP) infusion in patients having falls would reverse vitamin K antagonists (VKAs) and that reversal would decrease delayed intracranial hemorrhage (ICH). METHODS: A retrospective review of patients with trauma admitted to a level 2 community trauma center was performed from January 2010 until November 2012. Inclusion criteria were: ground level fall (GLF) with suspected head trauma, on VKA, an international normalized ratio (INR) of >1.5, and a negative head computed tomography (CT). Patients were transfused with FFP to a goal INR of <1.5 while observed. Patients were classified as reversed (REV) if the lowest INR achieved within 4 to 24 hours after initial INR was <1.5 or unreversed (NREV) if lowest INR achieved was >1.5. Chi-square and logistic regression were performed. RESULTS: A total of 194 patients met the criteria. In all, 43 (22%) patients were able to be REV, and 151 (78%) patients remained NREV. Unreversed patients were male and younger (P < .05). There was no difference in mean FFP received. Unreversed patients had a higher initial INR of 3.0 compared to REV patients (2.5; P = .018). One patient developed a delayed ICH and belonged to the REV group. CONCLUSION: The incidence of delayed hemorrhage was 0.5%. A strategy of prophylactic FFP infusion was ineffective in VKA reversal. We recommend against prophylactic infusion of FFP during a period of observation for patients on VKA with suspected head trauma and a negative initial CT.

Laparoscopic Versus Open Bowel Resection in Emergency Small Bowel Obstruction: Analysis of the National Surgical Quality Improvement Program Database.

BACKGROUND: Small bowel obstruction (SBO) is commonly encountered by surgeons and has traditionally been handled via an open approach, especially when small bowel resection (SBR) is indicated, although recent series have shown improved outcomes with a laparoscopic approach. In this retrospective study, we sought to evaluate outcomes and identify risk factors for adverse events after emergency SBR for SBO with an emphasis on surgical approach. MATERIALS AND METHODS: In this retrospective review using American College of Surgeons National Surgical Quality Improvement Program data, 1750 patients were identified who had emergency SBR with the principal diagnosis of SBO from 2006 to 2011. Mortality and postoperative adverse events were evaluated. RESULTS: Of 1750 patients who had emergency SBR, 51 (2.9%) had laparoscopic bowel resection (LBR). There was no difference in surgery duration (open bowel resection [OBR] versus LBR, 100 minutes versus 92 minutes; P=.38). Compared with the LBR group, the OBR group had a higher rate of baseline cardiac comorbidities and postoperative complications, and their length of stay was longer (10 versus 8 days; P<.001). Using multivariate analysis, perioperative variables of age >70 years, pulmonary, renal, neurological, and cardiac comorbidities, preoperative sepsis, steroid use, and body mass index of <30 kg/m(2) were associated with increased odds of mortality. OBR was associated with overall increased odds of morbidity (2.8; P=.003) and postoperative wound (2.9; P=.018) and respiratory (6.5; P=.011) infections. CONCLUSIONS: LBR was associated with equivalent operative time, shorter length of stay, less morbidity, and equivalent mortality compared with OBR. Although therapy for SBO secondary to adhesive disease remains controversial, our study shows numerous benefits to the laparoscopic approach to SBOs and thus should be considered a first-line treatment option for the management of this common surgical problem.

Causes and Timing of Nonelective Reoperations After Bariatric Surgery: A Review of 1304 Cases at a Single Institution.

As the number of patients undergoing bariatric procedures for weight loss increases, an understanding of the causes and timing of complications requiring reoperation is critical. The aim of our study was to characterize the type and timing of nonelective (NE) reoperations in these patients. Over five years, 1304 patients undergoing index procedures were identified: 769 laparoscopic Roux-en-Y gastric bypasses (LRYGB), 301 laparoscopic sleeve gastrectomies, and 234 laparoscopic adjustable gastric bands. We identified 117 NE reoperations, which were grouped by index procedure as well as whether they occurred early (≤90 days) or late (>90 days). In the laparoscopic adjustable gastric bands group, slipped gastric band was the most common indication for early (n = 2) and late (n = 2) reoperations. Biliary disease was the most common cause for early reoperations (n = 4), and the only cause for late reoperations (n = 2) after laparoscopic sleeve gastrectomies. For LRYGB, diagnoses differed between the early and late groups, with the most common early indications being bowel obstruction (n = 8) and anastomotic leak (n = 4) of the 18 early reoperations, and internal hernia (n = 36) and biliary disease (n = 17) of the 82 late reoperations. The vast majority of NE reoperations were performed laparoscopically (92%), with conversions and primarily open procedures only occurring in the LRYGB group.

Periprosthetic Anesthetic for Postoperative Pain After Laparoscopic Ventral Hernia Repair: A Randomized Clinical Trial.

IMPORTANCE: Laparoscopic ventral hernia repair (LVHR) using mesh is a well-established intervention for ventral hernia, but pain control can be challenging. OBJECTIVE: To determine whether instillation of a long-acting local anesthetic between the mesh and the peritoneum after LVHR reduces pain or narcotic requirements. DESIGN, SETTING, AND PARTICIPANTS: A prospective, double-blind, randomized clinical trial with data collection during a brief hospital stay in a tertiary care, community teaching hospital over 3 years between December 15, 2011, and March 28, 2014. Of 120 screened patients undergoing LVHR in this intention-to-treat analysis, 99 eligible patients were randomized. Forty-two patients received the study drug, and 38 patients received placebo. Patients with a history of chronic narcotic use were excluded. INTERVENTION: After mesh placement, a long-acting local anesthetic (bupivacaine hydrochloride, 0.50%) or placebo (0.9% normal saline) was injected between the mesh and the peritoneum. MAIN OUTCOMES AND MEASURES: Postoperative pain (on a standard scale ranging from 0 to 10), and narcotic medication use (intravenous morphine equivalents). There were no adverse events. RESULTS: Baseline and operative characteristics were similar except that the treatment group was older (61.8 vs 52.3 years, P = .001). After surgery, pain scores in the recovery room (3.2 vs 4.7, P = .003), interval total narcotic use (6.7 vs 12.5 mg, P = .003 at <4 hours and 0 vs 2.7 mg, P = .01 at 8-12 hours), and total intravenous narcotic use (9.2 vs 17.2 mg of morphine sulfate equivalents, P = .03) were significantly less in the treatment group. CONCLUSIONS AND RELEVANCE: Administration of a long-acting local anesthetic between the mesh and the peritoneum significantly reduces postoperative pain and narcotic use after LVHR. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01530815.

Incidence of intracranial hemorrhage and outcomes after ground-level falls in geriatric trauma patients taking preinjury anticoagulants and antiplatelet agents.

Antiplatelet and anticoagulant medication increases the risk of intracranial hemorrhage (ICH) after a fall in geriatric patients. We sought to determine whether there were differences in ICH rates and outcomes based on type of anticoagulant or antiplatelet agent after a ground-level fall (GLF). Our institutional trauma registry was used to identify patients 65 years old or older after a GLF while taking warfarin, clopidogrel, or aspirin over a 2-year period. Rates and types of ICH and patient outcomes were evaluated. Of 562 patients who met inclusion and exclusion criteria, 218 (38.8%) were on warfarin, 95 (16.9%) were on clopidogrel, and 249 (44.3%) were on aspirin. Overall ICH frequency was 15 per cent with no difference in ICH rate, type of ICH, need for craniotomy, mortality, or intensive care unit or hospital length of stay between groups. Patients with ICH were more likely to present with abnormal Glasgow Coma Score, history of hypertension, and/or loss of consciousness.