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1.
J Surg Res ; 298: 335-340, 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38663259

RESUMO

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.

2.
Surgery ; 175(5): 1418-1423, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38418296

RESUMO

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.


Assuntos
Traumatismos Abdominais , Embolia Pulmonar , Tromboembolia Venosa , Ferimentos não Penetrantes , Humanos , Anticoagulantes/uso terapêutico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Embolia Pulmonar/etiologia , Embolia Pulmonar/prevenção & controle , Baço/cirurgia , Hemorragia/etiologia , Hemorragia/prevenção & controle , Traumatismos Abdominais/complicações , Ferimentos não Penetrantes/complicações , Ferimentos não Penetrantes/terapia
3.
J Pediatr Surg ; 59(5): 889-892, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38383176

RESUMO

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.


Assuntos
Sistemas de Proteção para Crianças , Ferimentos e Lesões , Adolescente , Feminino , Humanos , Masculino , Acidentes de Trânsito , Veículos Automotores , Estudos Retrospectivos , Centros de Traumatologia
4.
Trauma Surg Acute Care Open ; 9(1): e001263, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38347895

RESUMO

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.

5.
J Pediatr Surg ; 59(3): 488-493, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37993397

RESUMO

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.


Assuntos
Centros de Traumatologia , Ferimentos e Lesões , Adulto , Criança , Humanos , Masculino , Feminino , Hospitalização , Mortalidade Hospitalar , Estudos Retrospectivos , Modelos Logísticos , Escala de Gravidade do Ferimento , Ferimentos e Lesões/terapia
6.
J Pediatr Surg ; 59(1): 134-137, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37858390

RESUMO

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.


Assuntos
Criptorquidismo , Hérnia Inguinal , Lactente , Masculino , Humanos , Recém-Nascido , Hérnia Inguinal/complicações , Hérnia Inguinal/cirurgia , Hérnia Inguinal/diagnóstico , Estudos Retrospectivos , Criptorquidismo/complicações , Criptorquidismo/cirurgia , Recém-Nascido Prematuro , Orquidopexia/métodos , Herniorrafia/métodos
7.
J Am Coll Surg ; 237(5): 731-736, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-37417653

RESUMO

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.


Assuntos
Lista de Checagem , Projetos de Pesquisa , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamanho da Amostra
8.
Ann Surg ; 278(2): 161-165, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37203558

RESUMO

OBJECTIVE: Report the 2-year outcomes of a multicenter randomized controlled trial comparing robotic versus laparoscopic intraperitoneal onlay mesh ventral hernia repair. BACKGROUND: Ventral hernia repair is one of the most common operations performed by general surgeons. To our knowledge, no studies have been published to date comparing long-term outcomes of laparoscopic versus robotic ventral hernia repair. METHODS: The trial was registered at clinicaltrials.gov (NCT03490266). Clinical outcomes included surgical site infection, surgical site occurrence, hernia occurrence, readmission, reoperation, and mortality. RESULTS: A total of 175 consecutive patients were approached that were deemed eligible for elective minimally invasive ventral hernia repair. In all, 124 were randomized and 101 completed follow-up at 2 years. Two-year follow-up was completed in 54 patients (83%) in the robotic arm and 47 patients (80%) in the laparoscopic arm. No differences were seen in surgical site infection or surgical site occurrence. Hernia recurrence occurred in 2 patients (4%) receiving robotic repair versus in 6 patients (13%) receiving laparoscopic repair (relative risk: 0.3, 95% CI: 0.06-1.39; P =0.12). No patients (0%) required reoperation in the robotic arm whereas 5 patients (11%) underwent reoperation in the laparoscopic arm ( P =0.019, relative risk not calculatable due to null outcome). CONCLUSIONS: Robotic ventral hernia repair demonstrated at least similar if not improved outcomes at 2 years compared with laparoscopy. There is potential benefit with robotic repair; however, additional multi-center trials and longer follow-up are needed to validate the hypothesis-generating findings of this study.


Assuntos
Hérnia Ventral , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Estudos Prospectivos , Laparoscopia/métodos , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Infecção da Ferida Cirúrgica/epidemiologia , Telas Cirúrgicas
9.
Surg Infect (Larchmt) ; 24(5): 425-432, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37222708

RESUMO

Background: Necrotizing soft tissue infections (NSTIs) are rapidly spreading, life-threatening infections that require emergent surgical intervention with immediate antibiotic initiation. However, there is no consensus regarding duration of antibiotic therapy after source control. We hypothesized that a short course of antibiotic therapy is as effective as a long course of antibiotic therapy after final debridement for NSTI. Methods: A systematic review of the literature was performed using PubMed, Embase, and Cochrane Library from inception to November 2022. Observational studies comparing short (≤7 days) versus long (>7 days) antibiotic duration for NSTI were included. Primary outcome was mortality and secondary outcomes included limb amputation and Clostridium difficile infection (CDI). Cumulative analysis was performed with Fisher exact test. Meta-analysis was performed using a fixed effects model and heterogeneity was assessed using Higgins I2. Results: A total of 622 titles were screened and four observational studies evaluating 532 patients met inclusion criteria. Mean age was 52 years, 67% were male, 61% had Fournier gangrene. There was no difference in mortality when comparing short to long duration antibiotic agents on both cumulative analysis (5.6% vs. 4.0%; p = 0.51) and meta-analysis (relative risk, 0.9; 95% confidence interval, 0.8-1.0; I2 0; p = 0.19). There was no significant difference in rates of limb amputation (11% vs. 8.5%; p = 0.50) or CDI (20.8% vs. 13.3%; p = 0.14). Conclusions: Short duration antibiotic therapy may be as effective as longer duration antibiotic therapy for NSTI after source control. Further high-quality data such as randomized clinical trials are required to create evidence-based guidelines.


Assuntos
Antibacterianos , Infecções dos Tecidos Moles , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Antibacterianos/uso terapêutico , Infecções dos Tecidos Moles/cirurgia
10.
J Trauma Acute Care Surg ; 95(1): 111-115, 2023 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-37038260

RESUMO

BACKGROUND: Previous studies have debated the optimal time to perform excision and grafting of second- and third-degree burns. The current consensus is that excision should be performed before the sixth hospital day. We hypothesize that patients who undergo excision within 48 hours have better outcomes. METHODS: The American College of Surgeons Trauma Quality Programs data set was used to identify all patients with at least 10% total body surface area second- and third-degree burns from years 2017 to 2019. Patients with other serious injuries (any Abbreviated Injury Scale, >3), severe inhalational injury, prehospital cardiac arrest, and interhospital transfers were excluded. International Classification of Diseases, Tenth Revision , procedure codes were used to ascertain time of first excision. Patients who underwent first excision within 48 hours of admission (early excision) were compared with those who underwent surgery 48 to 120 hours from admission (standard therapy). Propensity score matching was performed to control for age and total body surface area burned. RESULTS: A total of 2,270 patients (72% male) were included in the analysis. The median age was 37 (23-55) years. Early excision was associated with shorter hospital length of stay (LOS), and intensive care unit LOS. Complications including deep venous thrombosis, pulmonary embolism, ventilator-associated pneumonia, and catheter-associated urinary tract infection were significantly lower with early excision. There was no significant difference in mortality. CONCLUSION: Performance of excision within 48 hours is associated with shorter hospital LOS and fewer complications than standard therapy. We recommend taking patients for operative debridement and temporary or, when feasible, permanent coverage within 48 hours. Prospective trials should be performed to verify the advantages of this treatment strategy. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.


Assuntos
Queimaduras , Embolia Pulmonar , Humanos , Masculino , Adulto , Feminino , Estudos Prospectivos , Queimaduras/cirurgia , Unidades de Terapia Intensiva , Escala Resumida de Ferimentos , Tempo de Internação , Estudos Retrospectivos
11.
J Am Coll Surg ; 236(1): 235-240, 2023 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-36102528

RESUMO

BACKGROUND: Operative reports are important documents; however, standards for critical elements of operative reports are general and often vague. Hernia surgery is one of the most common procedures performed by general surgeons, so the aim of this project was to develop a Delphi consensus on critical elements of a ventral hernia repair operative report. STUDY DESIGN: The Delphi method was used to establish consensus on key features of operative reports for ventral hernia repair. An expert panel was selected and questionnaires were distributed. The first round of voting was open-ended to allow participants to recommend what details should be included. For the second round the questionnaire was distributed with the items that did not have unanimous responses along with free text comments from the first round. RESULTS: Eighteen surgeons were approached, of which 11 completed both rounds. Twenty items were on the initial questionnaire, of which 11 had 100% agreement. Of the remaining 9 items, after the second questionnaire an additional 7 reached consensus. CONCLUSION: Ventral hernia repairs are a common and challenging problem and often require reoperations. Surgeons frequently refer to previous operative notes to guide future procedures, which requires detailed and comprehensive operative reports. This Delphi consensus was able to identify key components needed for an operative report describing ventral hernia repair.


Assuntos
Hérnia Ventral , Humanos , Consenso , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Técnica Delphi
12.
Ann Intern Med ; 174(8): 1110-1117, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34181448

RESUMO

BACKGROUND: Use of robot-assisted surgery has increased dramatically since its advent in the 1980s, and nearly all surgical subspecialties have adopted it. However, whether it has advantages compared with laparoscopy or open surgery is unknown. PURPOSE: To assess the quality of evidence and outcomes of robot-assisted surgery compared with laparoscopy and open surgery in adults. DATA SOURCES: PubMed, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials were searched from inception to April 2021. STUDY SELECTION: Randomized controlled trials that compared robot-assisted abdominopelvic surgery with laparoscopy, open surgery, or both. DATA EXTRACTION: Two reviewers independently extracted study data and risk of bias. DATA SYNTHESIS: A total of 50 studies with 4898 patients were included. Of the 39 studies that reported incidence of Clavien-Dindo complications, 4 (10%) showed fewer complications with robot-assisted surgery. The majority of studies showed no difference in intraoperative complications, conversion rates, and long-term outcomes. Overall, robot-assisted surgery had longer operative duration than laparoscopy, but no obvious difference was seen versus open surgery. LIMITATIONS: Heterogeneity was present among and within the included surgical subspecialties, which precluded meta-analysis. Several trials may not have been powered to assess relevant differences in outcomes. CONCLUSION: There is currently no clear advantage with existing robotic platforms, which are costly and increase operative duration. With refinement, competition, and cost reduction, future versions have the potential to improve clinical outcomes without the existing disadvantages. PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42020182027).


Assuntos
Abdome/cirurgia , Medicina Baseada em Evidências , Pelve/cirurgia , Procedimentos Cirúrgicos Robóticos , Humanos , Laparoscopia , Laparotomia , Complicações Pós-Operatórias
13.
Am J Med Sci ; 361(2): 151-168, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33526213

RESUMO

BACKGROUND: Disparity exists between men and women physicians. We aimed to examine changes in gender disparity in the medical profession over the last two decades. The study reviewed publications on gender differences and the measures which have been implemented or suggested to rectify these disparities. METHODS: Pubmed, Embase, Scopus, and The Cochrane Library were searched in December 2019 using ("gender disparity" OR "gender gap" OR "pay gap" OR "gender discrimination") from 1998-2019. The sources list of reviewed articles was also used to retrieve more relevant articles. Articles about physicians in the United States were included, and Critical Appraisal Skills Programme (CASP) was used to evaluate the quality of the articles. RESULTS: In this systematic review that includes 49 studies, there is still disparity and discrimination in research, leadership, and pay between male and female physicians. Women have less leadership roles and progress at a slower rate to associate and full professor. Women publish less articles and have a lower h-index than men. Men earn $20,000 more a year after salary adjustment. More women than men experience negative comments about their gender (36% vs 4%), experience gender discrimination (65% vs 10%) and sexual harassment (30% vs 6%). CONCLUSIONS: Although substantial research exists on this topic, there remains significant room for improvement to achieve gender equality. Institutions and individuals should implement interventions to rectify this disparity .


Assuntos
Médicos , Sexismo , Feminino , Humanos , Renda , Liderança , Masculino , Medicina , Pesquisa , Assédio Sexual , Estados Unidos
14.
Surg Infect (Larchmt) ; 22(5): 496-503, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33259771

RESUMO

Background: Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. Patients and Methods: We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Results: Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2-4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94-4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54-5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73-4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83-7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. Conclusions: In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.


Assuntos
Produtos Biológicos , Hérnia Ventral , Hérnia Ventral/cirurgia , Herniorrafia/efeitos adversos , Humanos , Projetos Piloto , Recidiva , Estudos Retrospectivos , Telas Cirúrgicas , Resultado do Tratamento
16.
World J Surg ; 44(8): 2572-2579, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32277279

RESUMO

BACKGROUND: The safety and effectiveness of expectant management (e.g., watchful waiting or initially managing non-operatively) for patients with a ventral hernia is unknown. We report our 3-year results of a prospective cohort of patients with ventral hernias who underwent expectant management. METHODS: A hernia clinic at an academic safety-net hospital was used to recruit patients. Any patient undergoing expectant management with symptoms and high-risk comorbidities, as determined by a surgeon based on institutional criteria, would be included in the study. Patients unlikely to complete follow-up assessments were excluded from the study. Patient-reported outcomes were collected by phone and mailed surveys. A modified activities assessment scale normalized to a 1-100 scale was used to measure results. The rate of operative repair was the primary outcome, while secondary outcomes include rate of emergency room (ER) visits and both emergent and elective hernia repairs. RESULTS: Among 128 patients initially enrolled, 84 (65.6%) completed the follow-up at a median (interquartile range) of 34.1 (31, 36.2) months. Overall, 28 (33.3%) patients visited the ER at least once because of their hernia and 31 (36.9%) patients underwent operative management. Seven patients (8.3%) required emergent operative repair. There was no significant change in quality of life for those managed non-operatively; however, substantial improvements in quality of life were observed for patients who underwent operative management. CONCLUSIONS: Expectant management is an effective strategy for patients with ventral hernias and significant comorbid medical conditions. Since the short-term risk of needing emergency hernia repair is moderate, there could be a safe period of time for preoperative optimization and risk-reduction for patients deemed high risk.


Assuntos
Hérnia Ventral/terapia , Herniorrafia/estatística & dados numéricos , Conduta Expectante , Adulto , Idoso , Comorbidade , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Emergências , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Seguimentos , Hérnia Ventral/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Qualidade de Vida
17.
Surgery ; 167(4): 743-750, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31980138

RESUMO

BACKGROUND: Our objective was to identify perceptions of the environment for women in surgery among 4 academic institutions. METHODS: Faculty surgeons and senior surgery residents were randomly selected to participate in a parallel study with concurrent quantitative and qualitative data collection. Outcomes were perceptions of the environment for women in surgery. Measures included semi-structured interviews, survey responses, and responses to scenarios. RESULTS: Saturation was achieved after 36 individuals were interviewed: 14 female (8 faculty, 6 residents) and 22 male (18 faculty, 4 residents) surgeons. Men (100%) and women (86%) reported gender disparity in surgery and identified 6 major categories which influence disparity: definitions of gender disparity, gaps in mentoring, family responsibility, disparity in leave, unequal pay, and professional advancement. Overall 94% of participants expressed concerns with gaps in mentoring, but 64% of women versus 14% of men reported difficulties finding role models who faced similar obstacles. Over half (53%) reported time with loved ones as their biggest sacrifice to advance professionally. Both female and male respondents expressed system-based biases favoring individuals willing to sacrifice family. A global subconscious bias against the expectations, abilities, and goals of female surgeons were perceived to impede promotion and advancement. CONCLUSION: Both female and male surgeons report substantial gender-based barriers in surgery for women. Despite improvements, fundamental issues such as lack of senior role models, limited support for surgeons with families, and disparities in hiring and promotion persist. This is an opportunity to make substantive changes to the system and eliminate barriers for women joining surgery, advancing their careers, and achieving their goals in a timely fashion.


Assuntos
Cirurgia Geral , Liderança , Médicas , Sexismo , Docentes de Medicina , Feminino , Humanos , Internato e Residência , Masculino , Percepção
18.
J Surg Res ; 247: 445-452, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31668430

RESUMO

BACKGROUND: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. MATERIALS AND METHODS: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. RESULTS: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. CONCLUSIONS: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.


Assuntos
Ensaios Clínicos como Assunto/normas , Conflito de Interesses/economia , Aprovação de Equipamentos/normas , Herniorrafia/instrumentação , Telas Cirúrgicas/efeitos adversos , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Aprovação de Equipamentos/legislação & jurisprudência , Herniorrafia/efeitos adversos , Humanos , Recall de Dispositivo Médico/legislação & jurisprudência , Recall de Dispositivo Médico/normas , Retirada de Dispositivo Médico Baseada em Segurança/legislação & jurisprudência , Retirada de Dispositivo Médico Baseada em Segurança/normas , Telas Cirúrgicas/economia
19.
J Surg Res ; 248: 117-122, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31884175

RESUMO

BACKGROUND: Women remain under-represented in academic surgery despite increasing percentages of female surgeons and surgery residents. Publications and leadership positions are used for hiring and promoting academic surgeons. We sought to determine the disparity of female authorship when compared with male authors in surgical peer-reviewed publications. METHODS: PubMed was searched for surgical publications from the United States. Obstetrics and gynecology was selected as a control specialty owing to its history of high female representation. Thirteen other surgical specialties were randomly selected from the Accreditation Council for Graduate Medical Education specialty list. Manuscripts from four time periods, 2000-2005, 2006-2010, 2011-2015, and 2016-2017, were randomly selected, and the gender of the first and last authors was determined. The Accreditation Council for Graduate Medical Education and Association of American Medical Colleges databases were used to determine women representation in surgery. Trends were assessed using the Cochran-Armitage test. RESULTS: In total, 560 manuscripts in 14 specialties were reviewed. In the control specialty, 51% of first authors were female compared with 18% of those in study specialties, and 39% of last authors were female compared with 11% of those in study specialties. No difference was found when comparing the gender of first (P-value = 0.393) and/or last authors (P-value = 0.281) with the proportion of female residents and attendings. CONCLUSIONS: Women surgeons publish research at a rate proportional to the number of females involved in that specialty. Disparities in leadership roles are unlikely explained by differences in publications. Instead, disparities are likely due to other reasons such as failure to attract women to academic surgery and failure to promote and mentor women surgeons into leadership positions.


Assuntos
Autoria , Médicas , Cirurgiões , Feminino , Humanos , Fator de Impacto de Revistas , Liderança , Masculino , Estudos Retrospectivos , Sexismo
20.
Am J Surg ; 218(6): 1234-1238, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31421893

RESUMO

BACKGROUND: We hypothesized that long-term quality of life (QoL) is improved among patients with ventral hernias (VHs) and comorbid conditions managed operatively than with non-operative management. METHODS: This was the 3-year follow-up to a prospective observational study of patients with comorbid conditions and VHs. Primary outcome was change in QoL measured utilizing the modified Activities Assessment Scale (AAS), a validated, hernia-specific survey. Outcomes were compared using: (1)paired t-test on matched subset and (2)multivariable linear regression on the overall cohort. RESULTS: In the matched cohort (n = 80; 40/group), the operative group experienced a significantly greater improvement in QoL compared to the non-operative group (28.4 ±â€¯27.1 vs. 11.8 ±â€¯23.8,p = 0.005). The operative group, had 10 (25.0%) reported recurrences while the non-operative group, reported 4/15 (26.7%) recurrences among the 15 (37.5%) patients that underwent repair. On multivariable analysis of the whole cohort (n = 137), operative management was associated with a 19.5 (95% CI7.0-31.9) point greater improvement in QoL compared to non-operative management. CONCLUSIONS: This is the first long term prospective study showing the benefits of operative as opposed to non-operative management of patients with comorbid conditions and VHs.


Assuntos
Tratamento Conservador , Hérnia Ventral/terapia , Herniorrafia , Qualidade de Vida , Adulto , Estudos de Casos e Controles , Comorbidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários , Resultado do Tratamento , Conduta Expectante
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