RESUMO
BACKGROUND: Promoting residents' wellbeing and decreasing burnout is a focus of Graduate Medical Education (GME). A supportive clinical learning environment is required to optimize residents' wellness and learning. OBJECTIVE: To determine if longitudinal assessments of burnout and learning environment as perceived by residents combined with applying continuous quality Model for Improvement and serial Plan, Do, Study, Act (PDSA) cycles to test interventions would improve residents' burnout. METHODS: From November 2017 to January 2020, 271 GME residents in internal medicine, general surgery, psychiatry, emergency medicine, family medicine and obstetrics and gynecology, were assessed over five cycles by Maslach Burnout Inventory (MBI), and by clinical learning environment factors (which included personal/social relationships, self-defined burnout, program burnout support, program back-up support, clinical supervision by faculty, and sleep difficulties). The results of the MBI and clinical learning environment factors were observed and analyzed to determine and develop indicated Institutional and individual program interventions using a Plan, Do, Study, Act process with each of the five cycles. RESULTS: The response rate was 78.34%. MBI parameters for all GME residents improved over time but were not statistically significant. Residents' positive perception of the clinical supervision by faculty was significantly and independently associated with improved MBI scores, while residents' self-defined burnout; and impaired personal relations perceptions were independently significantly associated with adverse MBI scores on liner regression. For all GME, significant improvements improved over time in residents' perception of impaired personal relationships (p < 0.001), self-defined burnout (p = 0.013), program burn-out support (p = 0.002) and program back-up support (p = 0.028). For the Internal Medicine Residency program, there were statistically significant improvements in all three MBI factors (p < 0.001) and in clinical learning environment measures (p = 0.006 to < 0.001). Interventions introduced during the PDSA cycles included organization-directed interventions (such as: faculty and administrative leadership recruitment, workflow interventions and residents' schedule optimization), and individual interventions (such as: selfcare, mentoring and resilience training). CONCLUSION: In our study, for all GME residents, clinical learning environment factors in contrast to MBI factors showed significant improvements. Residents' positive perception of the clinical learning environment was associated with improved burnout measures. Residents in separate programs responded differently with one program reaching significance in all MBI and clinical learning environment factors measured. Continuous wellbeing assessment of all GME residents and introduction of Institutional and individual program interventions was accomplished.
Assuntos
Esgotamento Profissional , Medicina de Emergência , Internato e Residência , Esgotamento Profissional/prevenção & controle , Esgotamento Psicológico , Educação de Pós-Graduação em Medicina/métodos , Medicina de Emergência/educação , Humanos , Inquéritos e QuestionáriosRESUMO
An open label, multicenter 16-week trial of cryopreserved human umbilical cord (TTAX01) was previously undertaken in 32 subjects presenting with a Wagner grade 3 or 4 diabetic foot ulcer, with 16 (50%) of these having confirmed closure following a median of one product application (previous study). All but two subjects (30/32; 94%) consented to participate in this follow-up study to 1-year postexposure. No restrictions were placed on treatments for open wounds. At 8-week intervals, subjects were evaluated for adverse events (AEs) and wound status (open or closed). Average time from initial exposure to end of follow-up was 378 days (range 343-433), with 29 of 30 (97%) subjects completing a full year. AEs were all typical for the population under study, and none were attributed to prior exposure to TTAX01. One previously healed wound re-opened, one previously unconfirmed closed wound remained healed, and nine new wound closures occurred, giving 25 of 29 (86.2%) healed in the ITT population. Three of the new closures followed the use of various tissue-based products. Three subjects whose wounds were healed required subsequent minor amputations due to osteomyelitis, one of which progressed to a major amputation (1/29; 3.4%). One additional subject underwent two minor amputations prior to healing. Overall, the study found TTAX01 to be safe in long-term follow-up and associated with both a low rate of major amputation and a higher than expected rates of healing.
Assuntos
Produtos Biológicos/uso terapêutico , Criopreservação , Pé Diabético/terapia , Cordão Umbilical/transplante , Cicatrização , Adulto , Idoso , Amputação Cirúrgica/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
Clinical trials of potential new therapies for diabetic foot ulcers rarely enroll patients whose wounds extend to muscle, fascia, or bone with clinical and radiographic evidence of underlying osteomyelitis. An open-label, multicenter trial of cryopreserved human umbilical cord (TTAX01) was undertaken in 32 subjects presenting with such complex wounds with a mean duration of 6.1 ± 9.0 (range: 0.2-47.1) months and wound area at screening of 3.8 ± 2.9 (range: 1.0-9.6) cm2 . Aggressive surgical debridement at baseline resulted in 17 minor amputations and an increase in mean wound area to 7.4 ± 5.8 (range: 1.1-28.6) cm2 . All subjects were placed on systemic antibiotics for at least 6 weeks in conjunction with baseline application of TTAX01. Repeat applications were made at no less than 4-week intervals over the 16-week trial. Initial closure occurred in 18 of 32 (56%) wounds, with 16 (50%) of these having confirmed closure in 16 weeks with a median of one-product application. Cases with biopsy confirmed osteomyelitis (n = 20) showed initial closure in 12 (60%) wounds and confirmed closure in 10 (50%) wounds. Four of the five ulcers presenting as recurrences experienced confirmed closure. Mean overall time to healing was 12.8 ± 4.3 weeks. Mean wound area reduction from baseline was 91% for all wounds. Of the 16 wounds without confirmed closure during the 16-week treatment period, five (31.3%) achieved 99-100% wound area reduction by their final visit. The product was well tolerated. Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis; however, there were no major amputations.
Assuntos
Diabetes Mellitus Tipo 2/diagnóstico , Pé Diabético/terapia , Osteomielite/terapia , Cordão Umbilical/transplante , Cicatrização/fisiologia , Adulto , Idoso , Criopreservação/métodos , Desbridamento/métodos , Diabetes Mellitus Tipo 2/complicações , Pé Diabético/complicações , Pé Diabético/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteomielite/complicações , Osteomielite/diagnóstico por imagem , Projetos Piloto , Prognóstico , Medição de Risco , Índice de Gravidade de DoençaRESUMO
INTRODUCTION: Gastric tumors confined to mucosa and submucosa can be resected with endoscopic resection techniques. They include endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) [1, 2]. These techniques can be challenging when the tumor is large or is near the gastroesophageal (GE) junction. Transgastric resection is a novel technique of removing gastric tumors that are unresectable by endoscopy due to their size and location. MATERIALS AND METHODS: We present a case of a 41-year-old male where a suspicious appearing lesion near the GE junction was removed using combined trans-gastric laparoscopic and endoscopic technique. The stomach was inflated using endoscopy, and three 5-mm balloon-tipped trocars were inserted directly into the stomach. The lesion was lifted with submucosal injection of saline and was resected using ultrasonic dissection device. The specimen was retrieved using Rothnet through the endoscope. The mucosal defect was closed with absorbable sutures. Trocars were removed and gastrostomy sites were closed with Endostitch device. Swallow study done on post-op day 2 did not show any signs of leak. Patient was discharged home on post-op day 5. Final pathology was consistent with hyperplastic polyp. CONCLUSION: Proximal Gastric lesions can be safely removed with combined Laparoscopic trans-gastric and endoscopic approach.
Assuntos
Pólipos Adenomatosos/cirurgia , Junção Esofagogástrica/cirurgia , Mucosa Gástrica/patologia , Gastroscopia , Neoplasias Gástricas/cirurgia , Pólipos Adenomatosos/patologia , Adulto , Mucosa Gástrica/cirurgia , Humanos , Laparoscopia/métodos , Masculino , Neoplasias Gástricas/patologia , Resultado do TratamentoRESUMO
BACKGROUND: The role of fundoplication in addition to hiatal hernia repair has been controversial. The aim of this study was to compare quality of life related to gastroesophageal reflux disease (GERD) in patients who underwent intra-thoracic stomach repair with and without fundoplication. We proposed that the group without a fundoplication would have poorer quality of life due to continued symptoms. METHODS: All patients undergoing foregut surgery at the Creighton University Esophageal Center are entered in a prospectively maintained database. The database was queried to identify patients who underwent surgery for a near complete (>75 % of stomach in chest) intra-thoracic stomach with gastric volvulus between 2004 and 2013. A questionnaire was derived from the Quality of Life in Reflux and Dyspepsia and Frequency Scale for Symptoms of GERD questionnaires to assess for symptoms related to reflux, and this questionnaire was administered by phone. RESULTS: A total of 150 patients underwent repair of ITS during the study period. A total of 109 patients had ITS repair with fundoplication, while 41 had only ITS repair. Follow-up was available in 54 % of patients in the fundoplication group (median follow-up of 5.2 years) and in 49 % of patients in the non-fundoplication group (median follow-up of 4 years). Significantly, more patients woke up at night (p < 0.01) and found themselves coughing around mealtime (p < 0.01) in the fundoplication group. Patients in the non-fundoplication group had significantly more daytime reflux (p = 0.02). Despite these symptoms, only one patient in the fundoplication group and no patients in the non-fundoplication group admitted that these symptoms were severe enough to severely affect their quality of life. All other patients contacted felt satisfied, and >80 % rated their quality of life as either good or excellent. CONCLUSIONS: We conclude that there is not a significant difference in quality-of-life parameters on long-term follow-up between patients undergoing ITS repair with or without fundoplication.
Assuntos
Fundoplicatura/métodos , Refluxo Gastroesofágico/cirurgia , Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Qualidade de Vida , Volvo Gástrico/cirurgia , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Dor no Peito/etiologia , Bases de Dados Factuais , Feminino , Refluxo Gastroesofágico/complicações , Azia/etiologia , Hérnia Hiatal/complicações , Humanos , Laparoscopia , Refluxo Laringofaríngeo/etiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Volvo Gástrico/complicações , Inquéritos e Questionários , Resultado do TratamentoRESUMO
OBJECTIVES: To report 1- and 2-year clinical outcomes of patients receiving platinum chromium everolimus-eluting stents (PtCr-EES) in the prospective, single-arm PLATINUM small vessel (SV) and long lesion (LL) studies. BACKGROUND: Small vessel diameter and long lesion length are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation. METHODS: The PLATINUM SV study enrolled 94 patients with coronary artery lesions in vessels ≥2.25 mm to <2.50 mm in diameter and ≤28 mm in length. The PLATINUM LL study enrolled 102 patients with lesions >24 to ≤34 mm long in vessels ≥2.50 to ≤4.25 mm in diameter. The primary endpoint for both studies was target lesion failure (TLF) at 1 year compared to a prespecified performance goal based on outcomes with the TAXUS Express paclitaxel-eluting stent in small vessels and long lesions. RESULTS: One-year TLF rates with the PtCr-EES were significantly (P < 0.001) lower than the predetermined performance goals: 2.4% versus 21.1% in the SV cohort and 3.2% versus 19.4% in the LL cohort. Cumulative rates of TLF to 2 years were 4.7% in the SV cohort and 8.8% in the LL cohort. No myocardial infarction or ARC definite/probable stent thromboses occurred in either cohort through 2-year follow-up. CONCLUSIONS: The clinical efficacy and safety outcomes observed in these small vessel and long lesion cohorts support the use of the PtCr-EES in the treatment of small diameter vessels and long lesions.
Assuntos
Fármacos Cardiovasculares/administração & dosagem , Cromo , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Platina , Sirolimo/análogos & derivados , Idoso , Doença da Artéria Coronariana/diagnóstico , Europa (Continente) , Everolimo , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
AIM: Atrial fibrillation (AF) has been associated with higher morbidity after esophagectomy. The objective of this study is to identify the surgical risk factors associated with new-onset atrial fibrillation after esophagectomy. METHODS: After Institutional Review Board approval, a prospectively maintained database was retrospectively queried to identify patients who underwent esophagectomy between 2003 and 2013. Data variables collected include pre-operative, intra-operative, and post-operative factors. Appropriate statistical analysis is performed utilizing Sigmaplot(®) version 12.3. RESULTS: From 2003 to 2013, 245 esophagectomies were performed at our institution, of these, 192 (147 males, mean age of 62 ± 11.12 years) were included in the final analysis and 53 were excluded [25 Roux-en-Y reconstruction (including three Merendino procedures), 20 had AF before surgery, and eight with staged esophagectomy]. Of 192 esophagectomies, 160 had malignancy (138 adenocarcinoma and 22 squamous cell carcinoma) and 106 (66.25%) received neo-adjuvant therapy. Esophagectomies were performed with Ivor Lewis Mckeown approach in 78 patients [34 Minimally Invasive (MIE), 37 open, and 7 Hybrid], Ivor Lewis approach in 56 patients (31 MIE, 10 Open, 15 Hybrid) and Transhiatal approach in 58 patients (16 MIE and 42 Open). Gastric conduit was used in 185 patients and colonic conduit in seven patients. Overall 30-day or in-hospital mortality was 3.6% (7/192). Forty-five (23.4%) patients with esophagectomy developed new-onset AF. Median onset of AF was post-op day 3 (0-32). They were older (65.7 vs. 61.3, p = 0.021), with medical comorbidities (thyroid disorder, hyperlipidemia, and coronary artery disease; p < 0.05) and lower diffusion capacity on Pulmonary function test (80.16 vs. 87.74%, p = 0.02) and stayed longer in hospital (19 vs. 14 days, p < 0.001) with severe post-operative complications (Clavien score ≥ III) (69 vs. 35.3%, p < 0.001). Multiple logistic regression analysis showed transthoracic approach (OR = 3.71, CI = 1.23-11.17, p = 0.02) and thyroid disorder (OR = 6.29, CI = 1.54-25.65, p = 0.01), and severe post-op complications (OR = 3.34, CI = 1.20-9.28, p = 0.02) were significantly associated with the development of new-onset AF. CONCLUSIONS: Transthoracic approach is an independent risk factor for the development of new-onset AF after esophagectomy. New-onset AF is associated with severe post-operative complications and longer hospital stay. Minimally invasive approach does not decrease the incidence of new-onset AF.
Assuntos
Adenocarcinoma/cirurgia , Fibrilação Atrial/epidemiologia , Carcinoma de Células Escamosas/cirurgia , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Complicações Pós-Operatórias/epidemiologia , Fatores Etários , Idoso , Comorbidade , Doença da Artéria Coronariana/epidemiologia , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar , Humanos , Hiperlipidemias/epidemiologia , Incidência , Laparoscopia/métodos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Análise Multivariada , Capacidade de Difusão Pulmonar , Estudos Retrospectivos , Fatores de Risco , Doenças da Glândula Tireoide/epidemiologiaRESUMO
BACKGROUND: Objective assessment of postfundoplication anatomy is of utmost importance especially if reoperative intervention is being planned. There is a lack of uniformity in the description of endoscopic findings in these patients.The purpose of this study was to propose a classification for standardized endoscopic reporting of postfundoplication anatomy. METHODS: After institutional review board approval, preoperative endoscopic findings of patients who underwent reoperative intervention from 1992 to 2011 were reviewed a nd classified. The classification included four factors:E (distance of GEJ to crus), S (amount of gastric tissue between the GEJ and fundoplication), F (fundoplication configuration), and P (paraesophageal hernia). RESULTS: The endoscopic findings of 310 patients who underwent reoperative antireflux surgery were classified using the newly proposed classification model. A significant increase in the number of procedures was noted over the years.There was no change in presenting symptoms and patterns of failure over the years. The classification model was easily applicable to previous endoscopy reports. There was good symptom association with our classification model. DISCUSSION: An endoscopic anatomical classification is proposed for description of failed fundoplication. With this classification, we hope to fill the gap in developing a uniform classification of failed fundoplications. Further studies addressing widespread applicability and outcome analysis are needed.
Assuntos
Fundoplicatura/classificação , Refluxo Gastroesofágico/cirurgia , Laparoscopia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Falha de TratamentoRESUMO
BACKGROUND: Redo fundoplication (RF) is the mainstay of treatment for failed fundoplication. A subset of patients with failed fundoplication requires Roux-en-Y reconstruction (RNY) for symptom relief. The aim of this study was to compare the long-term subjective outcomes between RF and RNY in patients with failed fundoplication. METHODS: After Institutional Board Review approval, retrospective review of a prospective database identified 119 RF (mean = 54.1 years, 78 women) and 64 RNY (mean = 54.8 years, 35 women) patients who underwent reoperative surgery between December 2003 and September 2009. Data variables analyzed included demographics, esophageal manometry, 24-h pH study, type of procedure, perioperative findings, complications, pre- and postoperative symptom (heartburn, regurgitation, dysphagia, and chest pain) scores (scale 0-3), and patient satisfaction score (scale 1-10). Patients with grade 2 and 3 scores were considered to have significant symptoms. RESULTS: Patients who underwent RNY had a significantly higher body mass index, higher mean number of risk factors, and higher preoperative severity of heartburn and regurgitation compared to the RF group. Of the 183 patients, long-term (>3 years) follow-up was available for 132 (89 RF and 43 RNY) patients. Symptom severity significantly improved after both procedures, with the exception of dysphagia in the RNY group. Overall, there was no significant difference in patients' satisfaction between the RF and RNY groups. In subset analysis, patients with morbid obesity, esophageal dysmotility, or ≥4 risk factors have better satisfaction with RNY compared to RF (p = 0.027, 0.031, and 0.045, respectively). CONCLUSIONS: RF and RNY have equally good patient satisfaction at 3 years follow-up. RNY may have improved outcomes in patients who are morbid obese, have esophageal dysmotility, or have four or more risk factors.
Assuntos
Anastomose em-Y de Roux/métodos , Fundoplicatura/efeitos adversos , Fundoplicatura/métodos , Refluxo Gastroesofágico/cirurgia , Satisfação do Paciente , Adulto , Idoso , Idoso de 80 Anos ou mais , Transtornos de Deglutição/etiologia , Transtornos de Deglutição/cirurgia , Feminino , Seguimentos , Refluxo Gastroesofágico/complicações , Azia/complicações , Azia/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/complicações , Obesidade Mórbida/cirurgia , Período Pós-Operatório , Recidiva , Reoperação , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Construction of intestinal anastomosis is a fundamental general surgery skill. New constraints in creating safe, effective anastomoses are faced, however, even as minimally invasive surgery techniques continue to gain popular and scientific support. We present our experience in developing and testing a novel anastomotic device (AD) constructed of a shape memory metal, with long-term follow-up in a canine model. This device has the potential for both laparoscopic and endoscopic delivery because of its unique design and adaptable deployment system. Eight canines had gastroduodenal and jejunojejunal anastomoses formed with the AD: the gastroduodenal anastomosis by transecting the stomach immediately distal to the pylorus and forming a side-to-side functional end-to-end anastomosis and the jejunojejunal anastomosis similarly following transection in the mid-jejunum. Four animals were survived for 6 months, and 4 for 12 months. At the study's end, the animals were euthanized and the anastomotic sites harvested for both gross and microscopic pathology. Two animals developed postoperative complications: one a mechanical bowel obstruction from bedding ingestion that required laparotomy, and one an ileus that conservative management resolved. All animals survived to their endpoints, displaying normal growth and development. All jejunojejunal anastomoses had AD passage and microscopic evidence of complete healing. Meanwhile, none of the gastroduodenal devices passed, with microscopy demonstrating incomplete mucosalization. This AD is highly effective in forming jejunojejunal anastomoses. Gastroduodenal anastomoses, while highly functional, retained the device without complete healing. Future studies using a more human-like animal model and an anastomotic technique avoiding the thick pylorus muscle should yield better results.
Assuntos
Anastomose Cirúrgica/instrumentação , Procedimentos Cirúrgicos do Sistema Digestório/instrumentação , Anastomose Cirúrgica/métodos , Animais , Procedimentos Cirúrgicos do Sistema Digestório/métodos , Cães , Duodeno/patologia , Duodeno/cirurgia , Jejunostomia , Jejuno/patologia , Jejuno/cirurgia , Masculino , Modelos AnimaisRESUMO
Abdominal hernia surgeries are commonly performed with many different approaches, and mesh utilization has become a cornerstone in hernia repair, ensuring durable outcomes with minimal recurrence risk. However, managing contaminated hernia repairs presents unique challenges due to the heightened risks of mesh infection. Recent advancements in lightweight macroporous polypropylene meshes offer promising solutions. Studies have highlighted the superiority of macroporous polypropylene meshes compared to primary suture repair and other mesh types in terms of reduced surgical site infection rates and lower hernia recurrence rates. Moreover, utilizing macroporous polypropylene mesh in the retrorectus plane is associated with a favorable salvage rate, underscoring its efficacy in contaminated hernia repairs. At the same time, contrary evidence suggests higher postoperative complications with mesh use in settings of clean-contaminated or contaminated fields. Most significant complications are increased infection rates and similar recurrence rates compared to mesh-free repairs. New synthetic mesh that is being marketed as having better outcomes than other types of mesh and potentially primary repair need to be carefully assessed as biologic mesh once used to also be touted as the mesh to use in such fields, but more research is showing higher complication rates. The risk of infection and consequent morbidity might outweigh the benefit of less recurrence risk with mesh use. Further research, including prospective studies with long-term follow-up, is warranted to elucidate optimal hernia repair strategies in contaminated fields and inform evidence-based practice guidelines.
RESUMO
BACKGROUND: Many patients with venous leg ulcers do not heal with standard care. HP802-247 is a novel spray-applied cell therapy containing growth-arrested allogeneic neonatal keratinocytes and fibroblasts. We compared different cell concentrations and dosing frequencies of HP802-247 for benefit and harm when applied to chronic venous leg ulcers. METHODS: We enrolled adult outpatients from 28 centres in the USA and Canada with up to three ulcers, venous reflux confirmed by doppler ultrasonography, and adequate arterial flow in this phase 2, double-blind, randomised, placebo-controlled trial if at least one ulcer measured 2-12 cm(2) in area and had persisted for 6-104 weeks. Patients were randomly assigned by computer-generated block randomisation in a 1:1:1:1:1 ratio to 5·0×10(6) cells per mL every 7 days or every 14 days, or 0·5×10(6) cells per mL every 7 days or every 14 days, or to vehicle alone every 7 days. All five groups received four-layer compression bandages. The trial sponsor, trial monitors, statisticians, investigators, centre personnel, and patients were masked to treatment allocation. The primary endpoint was mean percentage change in wound area at the end of 12 weeks. Analyses were by intention to treat, excluding one patient who died of unrelated causes before first treatment. This trial is registered with ClinicalTrials.gov NCT00852995. FINDINGS: 45 patients were assigned to 5·0×10(6) cells per mL every 7 days, 44 to 5·0×10(6) cells per mL every 14 days, 43 to 0·5 ×10(6) cells per mL every 7 days, 46 to 0·5 ×10(6) cells per mL every 14 days, and 50 to vehicle alone. All required visits were completed by 205 patients. The primary outcome analysis showed significantly greater mean reduction in wound area associated with active treatment compared with vehicle (p=0·0446), with the dose of 0·5 ×10(6) cells/mL every 14 days showing the largest improvement compared with vehicle (15·98%, 95% CI 5·56-26·41, p=0·0028). Adverse events were much the same across all groups, with only new skin ulcers and cellulitis occurring in more than 5% of patients. INTERPRETATION: Venous leg ulcers can be healed with a spray formulation of allogeneic neonatal keratinocytes and fibroblasts without the need for tissue engineering, at an optimum dose of 0·5×10(6) cells per mL every 14 days. FUNDING: Healthpoint Biotherapeutics.
Assuntos
Fibroblastos/transplante , Queratinócitos/transplante , Úlcera Varicosa/terapia , Idoso , Método Duplo-Cego , Feminino , Humanos , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Úlcera Varicosa/patologia , Úlcera Varicosa/fisiopatologia , CicatrizaçãoRESUMO
OBJECTIVE: To examine patient and wound variables presumed to influence healing outcomes in the context of therapeutic trials for chronic venous leg ulcers. METHODS: This double-blind, vehicle-controlled study was conducted with randomized assignment to one of four cell therapy dose groups (n = 46, 43, 44, 45) or vehicle control (n = 50). A 2-week run-in period was used to exclude rapid healers and those with infection or uncontrolled edema. This was a multicenter (ambulatory, private, hospital-based and university-based practices, and wound care centers in North America) study. Adults ≥ 18 years old with chronic venous insufficiency associated with an uninfected venous leg ulcer (2-12 cm(2) area, 6-104 weeks' duration) were included in the study. Excluded were pregnant or lactating women, wounds with exposed muscle, tendon or bone, patients unable to tolerate compression bandages, or patients who had exclusionary medical conditions or exposure to certain products. Exclusion during run-in included patients with infection, uncontrolled severe edema or with healing rates ≥ 0.349 cm/2 wk. Screen fail rate was 37% (134/362), and the withdrawal rate was~10% (23 of 228). Growth-arrested neonatal dermal fibroblasts and keratinocytes were delivered via pump spray in a fibrin sealant-based matrix, plus a foam dressing and four-layer compression bandaging. Treatment continued for 12 weeks or until healed, whichever occurred first. Patient demographic and wound-related variables were evaluated for influence on complete wound healing in all patients, as well as the subsets of treated and control patients. RESULTS: Wound duration (P = .004) and the presence of specific quantities of certain bacterial species (P < .001) affected healing in the vehicle group, while healing in the cell-treated groups was influenced by wound duration (P = .012), wound area (P = .026), wound location (P = .011), and specific quantities of certain bacterial species (P = .002). Age, sex, race, diabetes, HbA1C, peripheral neuropathy, and serum prealbumin did not significantly affect healing. Body mass index was positively associated with healing in cell-treated patients. CONCLUSIONS: Wound duration is a quantifiable surrogate for one or more undefined variables that can have a profound negative effect on venous leg ulcer healing. Although cell therapy overcame barriers to healing, the only specific barrier identified was the presence of certain bacterial species. Interventional trials of potentially effective new therapies can be most informative when patients with suspected barriers to healing are included. The specific measurement of candidate barriers such as microbial pathogens, wound inflammatory state, and fibroblast function should be considered in future randomized trials to improve our understanding of the basis for chronicity.
Assuntos
Pontos de Checagem do Ciclo Celular , Fibroblastos/transplante , Queratinócitos/transplante , Úlcera Varicosa/cirurgia , Insuficiência Venosa/cirurgia , Cicatrização , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/uso terapêutico , Distribuição de Qui-Quadrado , Doença Crônica , Bandagens Compressivas , Desbridamento , Método Duplo-Cego , Feminino , Adesivo Tecidual de Fibrina , Humanos , Modelos Lineares , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Curativos Oclusivos , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Transplante Homólogo , Resultado do Tratamento , Estados Unidos , Úlcera Varicosa/diagnóstico , Úlcera Varicosa/microbiologia , Insuficiência Venosa/diagnóstico , Infecção dos Ferimentos/microbiologiaRESUMO
Patients who participated in a Phase 2 trial of HP802-247 for venous leg ulcers were invited to participate in this 24-week follow-up study to assess the durability of healing, document additional ulcer closures, and evaluate posttreatment safety. Consent was given by 90% (206/228), with 80% (183/228) completing all visits. Blinding was retained from the previous trial in which subjects had been randomized to vehicle or one of four cell therapy regimens. Visits were every 8 weeks. Among the 183 subjects, 43% (21/49) previously treated with cells and entering follow-up with an open wound achieved closure, compared with 35% (7/20) previously treated with vehicle, while 10% (11/106) and 17% (3/18), respectively, experienced reopening of a previously closed wound. Subjects previously treated with cells closed more open wounds than those previously treated with vehicle (OR 1.39, 95% CI 0.47-4.10; p = 0.739), and less subjects with a previously closed wound reopened (OR 0.65, CI 0.16-2.60; p = 0.821); however, these findings were not statistically significant. At the final visit, the difference in proportion of subjects with wounds closed continued to favor the best dose from the prior trial (83% closed vs. 58%, delta 25%). Follow-up beyond 12 weeks is necessary to evaluate the full benefit of this therapy, as treatment with cells may provide stimulus toward healing that persists for up to several weeks following the last application. The results show that the greater proportional benefit achieved by HP802-247 relative to standard care after 12 weeks of treatment persists over a meaningful timeframe.
Assuntos
Terapia Baseada em Transplante de Células e Tecidos/métodos , Fibroblastos/transplante , Queratinócitos/transplante , Úlcera da Perna/fisiopatologia , Insuficiência Venosa/fisiopatologia , Cicatrização , Feminino , Seguimentos , Humanos , Úlcera da Perna/etiologia , Úlcera da Perna/patologia , Úlcera da Perna/terapia , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Transplante Autólogo , Resultado do Tratamento , Estados Unidos/epidemiologia , Úlcera Varicosa/fisiopatologia , Insuficiência Venosa/complicações , Insuficiência Venosa/patologiaRESUMO
BACKGROUND: A subset of patients requires reoperative antireflux surgery (Re-ARS) after failed fundoplication. The aim of this study was to determine symptomatic outcomes beyond 1 year following Re-ARS and to assess the relative utility of two different surgical approaches. METHODS: After Institutional Review Board approval, patients who underwent Re-ARS were identified from a prospective database. Symptom severity was graded on a 0-3 scale. Patients with postoperative symptoms of grade ≥ 2 were considered to have a poor outcome. Patient satisfaction was graded using a 10-point visual analog scale. RESULTS: At least 1 year of follow-up was available for 130 patients. There were 94 redo fundoplications (RF) and 36 Roux-en-Y reconstructions (RNYR). Symptom risk factors (significant preoperative dysphagia, significant preoperative heartburn, esophageal dysmotility, short esophagus, delayed gastric emptying, multiple failed hiatal surgeries, reflux-related respiratory symptoms) were more prevalent in patients who underwent RNYR compared to RF (mean 3.0 vs. 2.2; p = 0.003). Postoperative leaks and major complications occurred in 4.5 % (5/110) versus 0% and 21.6 % versus 33.3 % of the RF and RNYR groups, respectively. Twenty-eight RF patients (29.8 %) and 9 RNYR patients (25.0 %) reported poor outcomes. Among patients with ≥ 4 risk factors, those who underwent RNYR had a lower incidence of poor outcome (7.7 % vs. 55 %, p = 0.018) and higher satisfaction scores (8.4 vs. 5.8, p = 0.001) compared to those who had RF. Overall, 85 % of patients were satisfied or highly satisfied with their results and the average satisfaction score was 8.2. CONCLUSION: Re-ARS provides good subjective outcomes when measured more than 1 year after surgery. Patients with more complex pathology benefit more from RNYR despite the higher postoperative complication rate. This is especially true for patients with decreased esophageal motility and short esophagus.
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Anastomose em-Y de Roux/métodos , Fundoplicatura/métodos , Refluxo Gastroesofágico/cirurgia , Anastomose em-Y de Roux/psicologia , Feminino , Fundoplicatura/psicologia , Humanos , Laparoscopia/métodos , Laparoscopia/psicologia , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Recidiva , Reoperação/métodos , Reoperação/psicologia , Fatores de Risco , Resultado do TratamentoRESUMO
Objectives: There is a paucity of data on pathway programs that seek to increase underrepresented in medicine (URiM) students in medicine. Therefore, this investigation aimed to describe the status and associations of pathway programs at US medical schools. Methods: From May to July 2021, the authors obtained information by (1) accessing pathway programs listed on the Association of American Medical Colleges (AAMC) website, (2) reviewing websites of US medical schools, (3) calling medical schools to obtain further information. The data retrieved from the medical school websites was compiled into a 27-item checklist based on the maximum number of different items that was extracted from any of the medical school websites. The data included program characteristics, curricula, activities, and outcomes. Each program was assessed on the number of categories of which information was available. Statistical analyses determined significant associations of URiM-focused pathways and other factors. Results: The authors identified 658 pathway programs: 153 (23%) listed on AAMC website and 505 (77%) identified from medical school websites. Only 88 (13%) programs listed outcomes and 143 (22%) had adequate website information. URiM-focused programs (48%) were independently associated with AAMC website listing (adjusted odds ratio [aOR] = 2.62, P = .001), no fees requirement (aOR = 3.33, P = .001), oversight by diversity departments (aOR = 2.05, P = .012), Medical College Admission Test preparations (aOR = 2.70, P = .001), research opportunities (aOR = 1.51, P = .022), and mentoring (aOR = 2.58., P < .001). Programs targeting K1-12 were less likely to offer mentoring, shadowing or research or include URiM students. Programs with outcomes were more likely to be college programs with longer durations and offer research, while programs listed on AAMC website provided more resources. Conclusion: Although pathway programs are available for URiM students, accessibility issues due to inadequate websites information and early exposure are barriers. Most programs have insufficient data on their website, including a lack of outcome data which is detrimental in today's virtual climate. Medical schools should update their websites to ensure that students requiring support to matriculate into medical school have adequate and relevant information to make informed decisions regarding participation.
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Background The Accreditation Council for Graduate Medical Education requires residents to demonstrate competence in integrating feedback into their daily practice. With the shift to virtual medical education during the pandemic, the need for new skills in delivering effective feedback through virtual media has emerged. Methodology This study aimed to assess the feasibility of a virtual bootcamp for interns, utilizing virtual simulation workshops to teach effective feedback skills. The curriculum employed a situated learning-guided participation framework. Virtual standardized students participated, and interns engaged in activities such as providing virtual feedback, completing self-assessments, and receiving instruction on feedback principles, including the one-minute preceptor's five micro-skills. Interns repeated the feedback process, with virtual students providing assessments. Data were collected from 105 incoming interns at Arrowhead Regional Medical Center in June 2021 and June 2022, using Zoom® as the online platform. Results Competency assessments revealed a significant post-training increase in proficiency/expert milestones (88% versus 47%, p = 0.007). Interns' self-assessments also significantly improved (18.02 versus 16.74, p = 0.001), particularly for previously trained interns (18.27 versus 16.7). Non-primary care interns outperformed primary care interns in milestone scores. The majority of interns (80%) reported valuable learning experiences during the workshop, with 70% expressing confidence in using the one-minute preceptor technique during residency. The one-minute preceptor step "reinforce what was right" was deemed the easiest, while "obtain commitment" and "explore emotional reaction" presented significant challenges. Conclusions This study demonstrates the potential of virtual workshops to enhance intern competency in delivering effective feedback through formal processes and the one-minute preceptor. These virtual approaches offer innovative alternatives to in-person teaching, enabling evaluation at higher levels of Miller's pyramid of clinical competence.
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BACKGROUND AND AIM: The objective of this study was to evaluate the association between high-resolution manometry (HRM) and impedance findings and symptoms in patients with nutcracker esophagus (NE). METHODS: After institutional review board approval retrospective review of a prospectively maintained database identified patients who were diagnosed with NE as per the Chicago classification (distal contractile integral [DCI] > 5000 mmHg-s-cm) at Creighton University between October 2008 and October 2010. Patients with achalasia or a history of previous foregut surgery were excluded. NE patients were sub-divided into: (i) Segmental (mean distal esophageal amplitude [DEA] at 3 and 8 cm above lower esophageal sphincter [LES] < 180 mmHg) (ii) Diffuse (mean DEA at 3 and 8 cm above LES > 180 mmHg) and (iii) Spastic (DCI > 8000 mmHg-s-cm). RESULTS: Forty-one patients (segmental: 13, diffuse: 4, spastic: 24) satisfied study criteria. Patients with segmental NE would have been missed by conventional manometry criteria as their DEA < 180 mmHg. A higher percentage of patients with spastic NE (63%) had chest pain when compared to patients with segmental NE (23%) and diffuse NE (25%). There was a significant positive correlation between chest pain severity score and DCI while there was no significant correlation between dysphagia severity and DCI. CONCLUSIONS: In patients diagnosed with NE using the Chicago classification presence and intensity of chest pain increases with increasing DCI. The present criteria (> 5000 mmHg-s-cm) seems to be too sensitive and has poor symptom correlation. Adjusting the criteria to 8000 mmHg-s-cm is more relevant clinically.
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Dor no Peito/complicações , Transtornos da Motilidade Esofágica/classificação , Transtornos da Motilidade Esofágica/fisiopatologia , Adulto , Dor no Peito/fisiopatologia , Transtornos da Motilidade Esofágica/complicações , Feminino , Humanos , Masculino , Manometria , Pessoa de Meia-Idade , Pletismografia de Impedância , Estudos Retrospectivos , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Fatores de TempoRESUMO
OBJECTIVE: Recurrent hiatus hernia is frequently found in patients undergoing reoperative antireflux surgery. The objective of this study is to report perioperative complications and subjective and objective outcomes for patients who underwent reoperative intervention for symptomatic large recurrent hiatus hernia. METHODS: Retrospective review of a prospectively maintained database was performed to identify patients with large (≥ 5 cm gastric tissue above the crus) recurrent hiatus hernia who underwent reoperation after failed antireflux surgery. Data for preoperative workup, operative procedure, and postoperative 6-month follow-up were reviewed and analyzed. RESULTS: Two hundred twenty patients underwent reoperation over a 6-year period. Forty-four patients had large recurrent hiatus hernia; 21 underwent redo fundoplication, while 23 underwent Roux-en-Y (RNY) reconstruction as remedial procedure. Short esophagus was found in 16 cases (6 of 21 redo Collis fundoplications, 10 of 23 RNY reconstructions). There was significant symptom improvement and high degree of satisfaction reported in both groups. However, patients with short esophagus did better with RNY reconstruction compared with redo Collis gastroplasty. CONCLUSIONS: Repair of large recurrent hiatus hernia is a technically challenging procedure; however, there is high degree of symptom resolution and patient satisfaction. RNY reconstruction might be a better alternative in patients with short esophagus compared with redo Collis gastroplasty.
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Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Complicações Intraoperatórias/etiologia , Complicações Pós-Operatórias/etiologia , Adulto , Idoso , Anastomose em-Y de Roux/métodos , Esôfago/cirurgia , Feminino , Seguimentos , Fundoplicatura/métodos , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/cirurgia , Hérnia Hiatal/complicações , Humanos , Jejuno/cirurgia , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Recidiva , Reoperação , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Reports on quality of life (QOL) after minimally invasive esophagectomy (MIE) have been limited. This report compares perioperative outcomes, survival, and QOL after MIEs with open transthoracic esophagectomy (TTE) and open transhiatal esophagectomy (THE). METHODS: After institutional review board approval, retrospective review of a prospectively maintained database identified patients who underwent esophageal resection for esophageal cancer at Creighton University between August 2003 and August 2010. Patients with preoperative stage 4 disease, emergent procedures, laparoscopic transhiatal esophagectomies, or esophagojeujunostomies were excluded from the study. The study patients were categorized as having undergone open TTE, open THE, or MIE. Overall survival (OS) was the interval between diagnosis and death or follow-up assessment. Disease-free survival (DFS) was the interval between surgery and recurrence, death, or follow-up assessment. For the patients who survived at least 1 year after surgery, QOL was assessed using European Organization for Research and Treatment of Cancer (EORTC-QLQ, version 3.0) and esophageal module (EORTC-QLQ OES 18) questionnaires. RESULTS: The study criteria were satisfied by 104 patients. Lymph node harvest with MIE (median = 20) was similar to that with open TTEs (median = 19) and significantly higher (P < 0.001) than that with open THEs (median = 12). The percentage of patients requiring intraoperative blood transfusion in the MIE group (23.4%) was significantly lower (P < 0.001) than in the open TTE (73.1%) and THE (67.7%) groups. The volume of intraoperative blood product transfusion was significantly lower for the MIE patients (median = 0 ml) than for the open TTE (median = 700 ml) and THE (median = 700 ml) patients. The incidence of respiratory complications with MIEs (10.64%) was significantly lower than with open TTEs (34.61%) and THEs (32.26%). The groups did not differ significantly in terms of R0 resection rates, OS, DFS, or QOL. CONCLUSIONS: MIEs offer a safe and viable alternative to open esophagectomies because they reduce the need and volume of intraoperative blood product transfusion and postoperative respiratory complications without compromising oncological clearance, survival, and QOL.