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3.
Ann Surg Open ; 1(2): e023, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37637447

RESUMO

Objective: To determine if Black race is associated with worse short-term postoperative morbidity and mortality when compared to White race in a contemporary, cross-specialty-matched cohort. Background: Growing evidence suggests poorer outcomes for Black patients undergoing surgery. Methods: A retrospective analysis was conducted comprising of all patients undergoing surgery in the National Surgical Quality Improvement Program dataset between 2012 and 2018. One-to-one coarsened exact matching was conducted between Black and White patients. Primary outcome was rate of 30-day morbidity and mortality. Results: After 1:1 matching, 615,118 patients were identified. Black race was associated with increased rate of all-cause morbidity (odds ratio [OR] = 1.10, 95% confidence interval [CI] 1.08-1.13, P < 0.001) and mortality (OR = 1.15, 95% CI 1.01-1.31, P = 0.039). Black race was associated with increased risk of re-intubation (OR = 1.33, 95% CI 1.21-1.48, P < 0.001), pulmonary embolism (OR = 1.55, 95% CI 1.40-1.71, P < 0.001), failure to wean from ventilator for >48 hours (OR = 1.14, 95% CI 1.02-1.29, P < 0.001), progressive renal insufficiency (OR = 1.63, 95% CI 1.43-1.86, P < 0.001), acute renal failure (OR = 1.39, 95% CI 1.16-1.66, P < 0.001), cardiac arrest (OR = 1.47, 95% CI 1.24-1.76 P < 0.001), bleeding requiring transfusion (OR = 1.39, 95% CI 1.34-1.43, P < 0.001), DVT/thrombophlebitis (OR = 1.24, 95% CI 1.14-1.35, P < 0.001), and sepsis/septic shock (OR = 1.09, 95% CI 1.03-1.15, P < 0.001). Black patients were also more likely to have a readmission (OR = 1.12, 95% CI 1.10-1.16, P < 0.001), discharge to a rehabilitation center (OR = 1.73, 95% CI 1.66-1.80, P < 0.001) or facility other than home (OR = 1.20, 95% CI 1.16-1.23, P < 0.001). Conclusion and Relevance: This contemporary matched analysis demonstrates an association with increased morbidity, mortality, and readmissions for Black patients across surgical procedures and specialties.

4.
Trials ; 16: 322, 2015 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-26223227

RESUMO

BACKGROUND: Surgical site infections (SSIs) are the second most common form of nosocomial infection. Colorectal resections have high rates of SSIs secondary to the inherently contaminated intraluminal environment. Negative pressure wound therapy dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. No randomized control trials exist to support the use of negative pressure wound therapy following elective open colorectal resection to reduce surgical site infection. METHODS/DESIGN: In this single-center, superiority designed prospective randomized open blinded endpoint controlled trial, patients scheduled for a colorectal resection via a laparotomy will be considered eligible. Patients undergoing laparoscopic resection will be enrolled but only randomized and included if the operation is converted to an open procedure. Exclusion criteria are patients receiving an abdominoperineal resection or a palliative procedure, as well as pregnant patients and those with an adhesive allergy. After informed consent, 300 patients will be randomized to the use of a standard adhesive gauze dressing or to a negative pressure wound device. Patients will be followed in hospital and reassessed on post-operative day 30. The primary outcome measure is SSI within the first 30 post-operative days. Secondary outcomes include the length of hospital stay, the number of return visits related to a potential or actual SSI, cost, and the need for homecare. The primary endpoint analysis follows the intention-to-treat principle. DISCUSSION: NEPTUNE is the first randomized controlled trial to investigate the role of incisional negative pressure wound therapy in decreasing the rates of surgical site infections in the abdominal incisions of patients following an elective, open colorectal resection. This low-risk intervention may help decrease the morbidity and costs associated with the development of an SSI in our patients. TRIAL REGISTRATION: NCT02007018--clinicaltrials.gov; 5 December 2013.


Assuntos
Colo/cirurgia , Infecção Hospitalar/prevenção & controle , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Tratamento de Ferimentos com Pressão Negativa , Reto/cirurgia , Infecção da Ferida Cirúrgica/prevenção & controle , Protocolos Clínicos , Infecção Hospitalar/diagnóstico , Infecção Hospitalar/economia , Infecção Hospitalar/microbiologia , Procedimentos Cirúrgicos do Sistema Digestório/economia , Serviços de Assistência Domiciliar , Custos Hospitalares , Humanos , Análise de Intenção de Tratamento , Tempo de Internação , Tratamento de Ferimentos com Pressão Negativa/efeitos adversos , Tratamento de Ferimentos com Pressão Negativa/economia , Ontário , Readmissão do Paciente , Estudos Prospectivos , Projetos de Pesquisa , Fatores de Risco , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/economia , Infecção da Ferida Cirúrgica/microbiologia , Fatores de Tempo , Resultado do Tratamento
5.
J Vasc Surg ; 61(6): 1624-34, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25769389

RESUMO

OBJECTIVE: Loss to follow-up (LTFU) can be a major difficulty for any clinical research study. The objective of this systematic review was to assess the extent of LTFU and its potential effect in studies of adult trauma patients with blunt thoracic aortic injuries (BTAIs). METHODS: Studies comparing management of BTAIs were systematically reviewed. Duplicate independent review was used for study selection, data abstraction, and critical appraisals. RESULTS: Thirty-six studies were included for synthesis, of which 94.1% applied a retrospective cohort design to prospective institutional databases. The mean LTFU at 1 year was 26.5% ± 31.6% for endovascular repair and 20.6% ± 34.2% for open repair groups. Not having a surgical/interventional specialist as a first or senior author was associated with a 39.7% higher LTFU at 1 year (P = .002). Studies with a higher risk of bias, later publication year, or North American origin were associated with a significantly higher risk for LTFU at 1 year (P ≤ .001). Nearly half of included studies assessed in-hospital outcomes exclusively. Only 38.2% explicitly reported LTFU data. Eight studies explicitly described the method of dealing with LTFU: eight used survival analysis and one used a national Social Security Death Index. Sensitivity analyses using plausible worst-case LTFU scenarios resulted in 14% to 17% of studies changing direction of effect. CONCLUSIONS: There is significant LTFU in trauma studies comparing operative methods for BTAIs. LTFU is generally handled and reported suboptimally, and sensitivity analyses suggest that study results are sensitive to differential LTFU. This has implications for the evidence-based choice of the operative method. Some protective factors that may aid in reducing LTFU were identified, one of which was involvement of a surgical or interventional specialist as a key author.


Assuntos
Aorta Torácica/cirurgia , Procedimentos Endovasculares , Perda de Seguimento , Traumatismos Torácicos/cirurgia , Procedimentos Cirúrgicos Vasculares , Lesões do Sistema Vascular/cirurgia , Ferimentos não Penetrantes/cirurgia , Aorta Torácica/lesões , Distribuição de Qui-Quadrado , Interpretação Estatística de Dados , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Procedimentos Endovasculares/estatística & dados numéricos , Humanos , Razão de Chances , Projetos de Pesquisa/estatística & dados numéricos , Fatores de Risco , Traumatismos Torácicos/diagnóstico , Traumatismos Torácicos/mortalidade , Fatores de Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade , Procedimentos Cirúrgicos Vasculares/estatística & dados numéricos , Lesões do Sistema Vascular/diagnóstico , Lesões do Sistema Vascular/mortalidade , Ferimentos não Penetrantes/diagnóstico , Ferimentos não Penetrantes/mortalidade
6.
Dis Colon Rectum ; 56(12): 1388-94, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24201393

RESUMO

BACKGROUND: Spin has been defined as "specific reporting that could distort the interpretation of results and mislead readers." OBJECTIVE: The purpose of this study was to identify how frequently, and to what extent, "spin" occurs in laparoscopic lower GI surgical trials with nonsignificant results. DATA SOURCES: Publications were referenced in MEDLINE and EMBASE (1992-2012). STUDY SELECTION: Randomized controlled trials comparing laparoscopic with open surgical technique in lower GI surgery were sought. Trials were included if a nonsignificant (p > 0.05) result of the primary outcome(s) occurred. INTERVENTION: The laparoscopic versus open technique in lower GI surgery was studied. MAIN OUTCOME MEASURES: Trials were assessed for frequency, strategy, and extent of "spin," as previously defined. RESULTS: Fifty-eight trials met the inclusion criteria. Sixty-six percent of these trials had evidence of "spin." In general, authors used significant results only (one of multiple primary outcomes, secondary outcomes, or subgroup analyses) (43%) or interpreted nonsignificance as equivalence (43%). Trials with spin were more likely to recommend the laparoscopic approach over the open technique (p < 0.001), were less likely to call for further trials (p = 0.003), and were less likely to acknowledge the nonsignificant differences (p < 0.001). Inadequate randomization was associated with decreased odds of spin (p = 0.03), as was an intent-to-treat analysis (p < 0.0001), whereas inadequate allocation concealment (p = 0.06) was weakly associated with a decrease in spin. No other a priori candidate risk factors were associated with the presence of spin. LIMITATIONS: Funding source was rarely described, so the association between industry funding and spin could not be assessed. CONCLUSION: The distortion of nonsignificant results in laparoscopic trials was highly prevalent in this review. Readers of trials with nonsignificant results should be cautious of the authors' interpretations. Editors, reviewers, and publishers should ensure that author's conclusions correspond to the study's results and design.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório/métodos , Laparoscopia/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Humanos , Resultado do Tratamento
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