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Objectives: To evaluate the impact of the COVID-19 pandemic on solid organ transplantation. Background: COVID-19 caused unprecedented disruption to solid organ transplantation (kidney, liver, heart, lung). Concerns about safety and decreases in deceased donors due to pandemic lockdowns have been described as potential causes. Methods: We report population-based rates of transplantation during the first 3 waves of COVID-19 in Ontario, Canada (March 1, 2020-July 3, 2021) versus a pre-COVID-19 baseline period (January 1, 2017-February 29, 2020). Poisson models were used to predict transplantation rates during COVID-19, based on pre-COVID-19 rates, and generate observed to expected rate ratios (RRs). Ninety-day transplant outcomes (mortality, retransplantation, transplant nephrectomy) were captured. Results: A 34.4% decrease (RR, 0.656; 95% confidence interval [CI], 0.586-0.734) in transplant rates was observed, coinciding with wave 1 and the deployment of a provincial transplant triaging system. Transplants decreased by 14.6% in wave 2 (RR, 0.854; 95% CI, 0.770-0.947) and 23.1% in wave 3 (RR, 0.769; 95% CI, 0.690-0.857) despite the triaging system not being activated. Overall, there was a 24.3% decrease (RR, 0.757; 95% CI, 0.679-0.844) in transplant rates, equivalent to 409 fewer transplants. No sustained changes were observed in heart or liver but sustained and large decreases were seen for lung (RR, 0.664; 95% CI, 0.482-0.915) and kidney (RR, 0.721; 95% CI, 0.602-0.863) transplantation. A low prevalence (1.7%) of COVID-19 infection within 90 days of transplantation was seen. No differences were observed in other 90-day outcomes. Conclusions: Early safety concerns limited transplantation to immediate life-saving procedures; however, the reductions in kidney and lung transplants continued for the rest of the pandemic, where no restrictions were in place.
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Tumor-specific overexpression of receptors enables a variety of targeted cancer therapies, exemplified by peptide-receptor radiotherapy (PRRT) for somatostatin receptor (SSTR)-positive neuroendocrine tumors. While effective, PRRT is restricted to tumors with SSTR overexpression. To overcome this limitation, we propose using oncolytic vaccinia virus (vvDD)-mediated receptor gene transfer to permit molecular imaging and PRRT in tumors without endogenous SSTR overexpression, a strategy termed radiovirotherapy. We hypothesized that vvDD-SSTR combined with a radiolabeled somatostatin analog could be deployed as radiovirotherapy in a colorectal cancer peritoneal carcinomatosis model, producing tumor-specific radiopeptide accumulation. Following vvDD-SSTR and 177Lu-DOTATOC treatment, viral replication and cytotoxicity, as well as biodistribution, tumor uptake, and survival, were evaluated. Radiovirotherapy did not alter virus replication or biodistribution, but synergistically improved vvDD-SSTR-induced cell killing in a receptor-dependent manner and significantly increased the tumor-specific accumulation and tumor-to-blood ratio of 177Lu-DOTATOC, making tumors imageable by microSPECT/CT and causing no significant toxicity. 177Lu-DOTATOC significantly improved survival over virus alone when combined with vvDD-SSTR but not control virus. We have therefore demonstrated that vvDD-SSTR can convert receptor-negative tumors into receptor-positive tumors and facilitate molecular imaging and PRRT using radiolabeled somatostatin analogs. Radiovirotherapy represents a promising treatment strategy with potential applications in a wide range of cancers.
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BACKGROUND: Emergency general surgery (EGS) conditions and their outcomes are perceived to be disproportionately high among solid organ transplant recipients (SOTRs). However, this has not been adequately investigated at a population level. We characterized the incidence and mortality of EGS conditions among SOTRs compared with nontransplant patients. METHODS: Data were collected through linked administrative population-based databases in Ontario, Canada. We included all adult SOTRs (kidney, liver, heart, and lung) who underwent transplantation between 2002 and 2017. We then identified posttransplantation emergency department visits for EGS conditions (appendicitis, cholecystitis, choledocolithiasis, perforated diverticulitis, incarcerated/strangulated hernias, small bowel obstruction, and perforated peptic ulcer). Age-, sex-, and year-standardized incidence rate ratios (SIRRs) were generated. Logistic regression models were used to evaluate association between transplantation status and 30 d mortality after adjusting for demographics, year, and comorbidities. RESULTS: Ten thousand seventy-three SOTRs and 12 608 135 persons were analyzed. SOTRs developed 881 EGS conditions (non-SOTRs: 552 194 events). The incidence of all EGS conditions among SOTR was significantly higher compared with the nontransplant patients [SIRR 3.56 (95% confidence interval [CI] 3.32-3.82)], even among those with high Aggregated Diagnosis Groups scores ( > 10) [SIRR 2.76 (95% CI 2.53-3.00)]. SOTRs were 1.4 times more likely to die at 30 d [adjusted odds ratio 1.44 (95% CI 1.08-1.91)] after an EGS event compared with nontransplant patients, predominantly amongst lung transplant recipients [adjusted odds ratio 3.28 (95% CI 1.72-6.24)]. CONCLUSIONS: The incidence of EGS conditions is significantly higher in SOTRs even after stratifying by comorbidity burden. This is of particular importance as SOTRs also have a higher likelihood of death after an EGS condition, especially lung transplant recipients.
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Trasplante de Órganos , Receptores de Trasplantes , Adulto , Humanos , Ontario/epidemiología , Incidencia , Comorbilidad , Trasplante de Órganos/efectos adversosRESUMEN
BACKGROUND: Living donor liver transplantation (LDLT) is an established treatment for advanced liver disease. Whether right lobe (RL) or left lobe (LL) LDLT provides the best outcomes for donors and recipients remains contentious. METHODS: MedLine, Embase, PubMed, and Cochrane Central were searched to identify studies comparing RL- and LL-LDLT and reporting donor and/or recipient outcomes. Effect sizes were pooled using random-effect meta-analysis. Meta-regressions were used to explore heterogeneity. RESULTS: Sixty-seven studies were included. RL donors were more likely to experience major complications (relative risk [RR] = 1.63; 95% confidence interval [CI] = 1.30-2.05; I2 = 19%) than LL donors; however, no difference was observed in the risk of any biliary complication (RR = 1.41; 95% CI = 0.91-2.20; I2 = 59%), bile leaks (RR = 1.56; 95% CI = 0.97-2.51; I2 = 52%), biliary strictures (RR = 0.99; 95% CI = 0.43-1.88; I2 = 27%), or postoperative death (RR = 0.51; 95% CI = 0.25-1.05; I2 = 0%). Among recipients, the incidence of major complications (RR = 0.85; 95% CI = 0.68-1.06; I2 = 21%), biliary complications (RR = 1.10; 95% CI = 0.91-1.33; I2 = 8%), and vascular complications (RR = 0.79; 95% CI = 0.44-1.43; I2 = 0%) was similar. Although the rate of small for size syndrome (RR = 0.47; 95% CI = 0.30-0.74; I2 = 0%) and postoperative deaths (RR = 0.62; 95% CI = 0.44-0.87; I2 = 0%) was lower among RL-LDLT recipients, no differences were observed in long-term graft (hazard ratio = 0.87; 95% CI = 0.55-1.38; I2 = 74%) and overall survival (hazard ratio = 0.86; 95% CI = 0.60-1.22; I2 = 44%). CONCLUSIONS: LL donors experience fewer complications than RL donors, and LL-LDLT recipients had similar outcomes to RL-LDLT recipients. These findings suggest that LL-LDLT offers the best outcomes for living donors and similar outcomes for recipients when measures are taken to prevent small for size syndrome.
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Trasplante de Hígado , Donadores Vivos , Humanos , Trasplante de Hígado/efectos adversos , Hepatectomía , Supervivencia de Injerto , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
Non-inferiority trials are used to test if a novel intervention is not worse than a standard treatment by more than a prespecified amount, the non-inferiority margin (ΔNI). The ΔNI indicates the amount of efficacy loss in the primary outcome that is acceptable in exchange for non-efficacy benefits in other outcomes. However, non-inferiority designs are sometimes used when non-efficacy benefits are absent. Without non-efficacy benefits, loss in efficacy cannot be easily justified. Further, non-efficacy benefits are scarcely defined or considered by trialists when determining the magnitude of and providing justification for the non-inferiority margin. This is problematic as the importance of a treatment's non-efficacy benefits are critical to understanding the results of a non-inferiority study. Here we propose the routine reporting in non-inferiority trial protocols and publications of non-efficacy benefits of the novel intervention along with the reporting of non-inferiority margins and their justification. The justification should include the specific trade-off between the accepted loss in efficacy (ΔNI) and the non-efficacy benefits of the novel treatment and should describe whether patients and other relevant stakeholders were involved in the definition of the ΔNI.
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Diverticulitis , Laparoscopía , Diverticulitis/cirugía , Humanos , Lavado Peritoneal , Irrigación TerapéuticaRESUMEN
INTRODUCTION: Resection for isolated distant recurrence of colon cancer is well accepted. Resection for locoregionally recurrent colon cancer (LRCC) is not well studied. We evaluated the long-term outcomes of curative-intent resection for LRCC. METHODS: All patients undergoing curative-intent resection for LRCC at three specialized cancer centers affiliated with the University of Toronto were identified (1993-2017). Follow-up included serial clinical assessment, colonoscopy, CEA, and cross-sectional imaging. Overall survival (OS), cancer-specific survival (CSS) and time to re-recurrence were estimated using Kaplan-Meier method and cumulative incidence function. The association between resection margins and outcome was assessed with Cox models. RESULTS: 117 patients were included in the study cohort. Median follow-up was 53 months (IQR: 34-101). OS was 75% (95% CI: 68-84) at 5 years, and 69% (95% CI: 59-79) at 10 years. CSS was 78% (95% CI: 70-86) at 5 years and 72% (95% CI: 63-83) at 10 years. The rate of re-recurrence was 22% (95% CI: 14-31) at 5 years, and 27% (95% CI: 16-39) at 10 years. Negative resection margin (R0) was associated with improved OS (HR 3.33, 95% CI: 1.85-6.00, p < 0.01). There were no postoperative deaths; complications with Clavien-Dindo grade > II occurred in 12% of patients. Perioperative chemotherapy was used in 63% of patients and radiotherapy in 37%. CONCLUSION: In selected patients with LRCC, excellent OS, CSS and low re-recurrence rates were observed, and R0 resection predicted better outcomes. These findings support consideration of resection for LRCC in fit patients after review at a multidisciplinary cancer conference.
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Adenocarcinoma/cirugía , Neoplasias del Colon/cirugía , Recurrencia Local de Neoplasia/cirugía , Adenocarcinoma/terapia , Anciano , Antineoplásicos/uso terapéutico , Neoplasias del Colon/patología , Neoplasias del Colon/terapia , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Márgenes de Escisión , Persona de Mediana Edad , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/terapia , Neoplasia Residual , Complicaciones Posoperatorias/etiología , Modelos de Riesgos Proporcionales , Radioterapia , Estudios Retrospectivos , Tasa de Supervivencia , Factores de TiempoRESUMEN
BACKGROUND: Red blood cell transfusions are common in patients undergoing gastrointestinal cancer surgery. Yet, to adequately balance their risks and benefits, clinicians must understand how transfusions may affect long-term outcomes. We aimed to determine if perioperative red blood cell transfusions are associated with a higher risk of all-cause and cancer-specific death among patients who underwent gastrointestinal cancer resection. METHOD: We identified a population-based cohort of patients who underwent gastrointestinal cancer resection in Ontario, Canada (2007-2019). All-cause death was compared between transfused and nontransfused patients using Cox proportional hazards regression, while cancer-specific death was compared with competing risk regression. RESULT: A total of 74,962 patients (mean age, 67.7 years; 55.4% male; 79.7% colorectal cancer) had gastrointestinal cancer surgery during the study period; 20.8% received perioperative red blood cell transfusions. Patients who received red blood cell transfusions had increased hazards of all-cause and cancer-specific death relative to patients who did not (hazard ratio: 1.39, 95% confidence interval 1.34-1.44; cause-specific hazard ratio: 1.36, 1.30-1.43). The adjusted risk of all-cause death was higher in early follow-up intervals (3-6 months postoperatively) but remained elevated in each interval over 5 years. The association persisted after restricting to patients without postoperative complications or bleeding and was robust to unmeasured confounding. CONCLUSION: Red blood cell transfusion among patients with gastrointestinal cancer is associated with increased all-cause death. This was observed long beyond the immediate postoperative period and independent of short-term postoperative morbidity and mortality. These findings should help clinicians balance the risks and benefits of transfusion before well-designed trials are conducted in this patient population.
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Transfusión de Eritrocitos/mortalidad , Neoplasias Gastrointestinales/mortalidad , Atención Perioperativa/mortalidad , Anciano , Causas de Muerte , Transfusión de Eritrocitos/efectos adversos , Transfusión de Eritrocitos/estadística & datos numéricos , Femenino , Neoplasias Gastrointestinales/cirugía , Humanos , Masculino , Ontario/epidemiología , Atención Perioperativa/efectos adversos , Atención Perioperativa/estadística & datos numéricos , Periodo Perioperatorio , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Background: There has been an increase in opioid usage and opioid-related deaths. Opioids prescribed to surgical patients have similarly increased. The aim of this study was to assess opioid consumption in patients undergoing laparoscopic appendectomy (LA) and laparoscopic cholecystectomy (LC) and to determine whether a standardized prescription could affect opioid consumption without affecting patient satisfaction. Methods: Patients undergoing LA or LC were recruited prospectively during 2 time periods (April to June 2017 and November 2017 to January 2018). In the first phase, surgeons continued their usual postoperative analgesia prescribing patterns. In the second phase, a standardized prescription was implemented. Patients were contacted by telephone and a questionnaire was completed for both phases of the study. The primary outcome was the quantity of opioids prescribed and consumed. Results: In the first phase, 166 patients who underwent LC or LA were recruited. The median number of prescribed opioid tablets was 20 and the median number consumed was 2. Ninety-five percent of patients reported satisfaction with their analgesia. Based on these results, a standardized prescription for multimodal analgesia was implemented for the second phase, consisting of 10 opioid tablets. In the second phase, 129 patients who underwent LA or LC were recruited. There was a significant decrease in the median number of opioid pills filled (10) and consumed (0), with no difference in reported satisfaction with analgesia. Conclusion: Patients are prescribed an excess of opioids after LA or LC. Implementation of a standardized prescription based on a quality improvement intervention was effective at decreasing the number of opioids prescribed and consumed.
Contexte: On a observé une augmentation de la consommation d'opioïdes, ainsi qu'une hausse des décès associés à ces substances. On a aussi constaté une augmentation semblable dans la prescription d'opioïdes aux patients ayant subi une chirurgie. La présente étude visait à évaluer la consommation d'opioïdes chez les personnes ayant subi une appendicectomie par laparoscopie (AL) ou une cholécystectomie par laparoscopie (CL), de même qu'à déterminer si une ordonnance normalisée pouvait modifier la consommation d'opioïdes sans nuire à la satisfaction des patients. Méthodes: Des patients devant subir une AL ou une CL ont été recrutés de façon prospective entre avril et juin 2017 et entre novembre 2017 et janvier 2018. Durant la première phase de l'étude, les chirurgiens ont maintenu leurs habitudes de prescription d'analgésie postopératoire. Durant la deuxième phase, toutefois, ils devaient avoir recours à une ordonnance normalisée. Dans les 2 phases de l'étude, les patients ont été joints par téléphone et un questionnaire a été rempli. Le principal résultat à l'étude était la quantité d'opioïdes prescrits et consommés. Résultats: Pour la première phase de l'étude, 166 patients ont été recrutés. Les nombres médians de comprimés prescrits et consommés étaient de 20 et de 2, respectivement. De tous les patients, 95 % se sont dits satisfaits de leur analgésie. Pour la deuxième phase, une ordonnance normalisée d'analgésie multimodale, qui comptait 10 comprimés, a été mise en place, et 129 patients ont été recrutés. On a alors observé une diminution significative du nombre médian de comprimés remis (10) et consommés (0), et aucune différence quant au degré de satisfaction déclaré. Conclusion: Les patients se voient prescrire trop d'opioïdes après une AL ou une CL. La création d'une ordonnance normalisée dans le cadre d'une intervention d'amélioration de la qualité a réduit efficacement le nombre de comprimés d'opioïdes prescrits et consommés.
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Analgésicos Opioides/uso terapéutico , Apendicectomía/métodos , Colecistectomía Laparoscópica , Prescripciones de Medicamentos/estadística & datos numéricos , Prescripciones de Medicamentos/normas , Utilización de Medicamentos/estadística & datos numéricos , Laparoscopía , Dolor Postoperatorio/tratamiento farmacológico , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: The main concern with live donor liver transplantation (LDLT) is the risk to the donor. Given the potential risk of liver insufficiency, most centers will only accept candidates with future liver remnants (FLR) >30%. We aimed to compare postoperative outcomes of donors who underwent LDLT with FLR ≤30% and >30%. METHODS: Adults who underwent right hepatectomy for LDLT between 2000 and 2018 were analyzed. Remnant liver volumes were estimated using hepatic volumetry. To adjust for between-group differences, donors with FLR ≤30% and >30% were matched 1:2 based on baseline characteristics. Postoperative complications including liver dysfunction were compared between the groups. RESULTS: A total of 604 live donors were identified, 28 (4.6%) of whom had a FLR ≤30%. Twenty-eight cases were successfully matched with 56 controls; the matched cohorts were mostly similar in terms of donor and graft characteristics. The calculated median FLR was 29.8 (range, 28.0-30.0) and 35.2 (range, 30.1-68.1) in each respective group. Median follow-up was 36.5 mo (interquartile range, 11.8-66.1). Postoperative outcomes were similar between groups. No difference was observed in overall complication rates (FLR ≤30%: 32.1% versus FLR >30%: 28.6%; odds ratio [OR], 1.22; 95% confidence interval [CI], 0.46-3.27) or major complication rates (FLR ≤30%: 14.3% versus FLR >30%: 14.3%; OR, 1.17; 95% CI, 0.33-4.10). Posthepatectomy liver failure was rare, and no difference was observed (FLR ≤30%: 3.6% versus FLR >30%: 3.6%; OR, 1.09; 95% CI, 0.11-11.1). CONCLUSION: A calculated FLR between 28% and 30% on its own should not represent a formal contraindication for live donation.
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Neoplasias Hepáticas , Trasplante de Hígado , Adulto , Estudios de Cohortes , Hepatectomía/efectos adversos , Humanos , Hígado/cirugía , Neoplasias Hepáticas/cirugía , Trasplante de Hígado/efectos adversos , Donadores Vivos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective of the study is to examine the analytic approach of meta-analyses that include noninferiority or equivalence (NI/EQ) trials. STUDY DESIGN AND SETTING: We used Scopus to identify meta-analyses including NI/EQ trials. We extracted data from the meta-analyses and their included randomized clinical trials (RCTs). We used the RCT's NI/EQ margins to reinterpret the results of the meta-analyses, assessed for risk of biases unique to NI/EQ trials, and evaluated the consistency of the meta-analysis interpretation when using NI/EQ margins. RESULTS: We identified 38 unique meta-analyses including 515 RCTs, of which 125 (24.3%) were NI/EQ trials. Fourteen meta-analyses (36.8%) reported the study design of their included trials, but only one (2.6%) interpreted their pooled estimates using NI/EQ margins and none assessed for risks of bias unique to NI/EQ trials. Nearly all NI/EQ trials (n = 116, 92.8%) included in the meta-analyses reported NI/EQ margins. The meta-analyses of 30 outcomes were reinterpreted using the NI/EQ margins; reinterpretations conflicted with the conclusion of the meta-analyses in most cases (n = 20, 66.7%). CONCLUSION: Most meta-analyses including NI/EQ trials ignore trial design and do not assess risks of bias unique to NI/EQ studies. Meta-analyses addressing questions previously explored as NI/EQ should conduct an NI/EQ meta-analysis or use clear language when performing standard (i.e., superiority) meta-analyses.
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Estudios de Equivalencia como Asunto , Metaanálisis como Asunto , Proyectos de Investigación , Sesgo , Bibliometría , Estudios Transversales , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricosRESUMEN
PURPOSE: Although there has been a significant increase in the use of oncoplastic surgery (OPS), data on the postoperative safety of this approach are limited compared to traditional lumpectomy. This study aimed to compare the immediate (30-day) postoperative complications associated with OPS and traditional lumpectomy. METHODS: An analysis of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database was performed on women with breast cancer who underwent OPS or traditional lumpectomy. Logistic regression was used to explore the effect of type of surgery on the outcome of interest. RESULTS: A total of 109,487 women were analyzed of whom 8.3% underwent OPS. OPS had a longer median operative time than traditional lumpectomy. The unadjusted immediate (30-day) overall complication rate was significantly higher with OPS than traditional lumpectomy (3.8% versus 2.6%, p < 0.001). After adjusting for baseline differences, overall 30-day postoperative complications were significantly higher amongst women undergoing OPS compared with traditional lumpectomy (OR 1.41, 95%CI 1.24-1.59). Factors that were independent predictors of overall 30-day complications included higher age, higher BMI, race, smoking status, lymph node surgery, neoadjuvant chemotherapy, ASA class ≥ 3, in situ disease, and year of operation. The interaction term between type of surgery and operative time was not statistically significant, indicating that operative time did not modify the effect of type of surgery on immediate postoperative complications. CONCLUSIONS: Although there were slightly higher overall complication rates with OPS, the absolute rates remained quite low for both groups. Therefore, OPS may be performed in women with breast cancer who are suitable candidates.
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Neoplasias de la Mama/cirugía , Carga Global de Enfermedades/estadística & datos numéricos , Mamoplastia/efectos adversos , Mastectomía Segmentaria/efectos adversos , Complicaciones Posoperatorias/epidemiología , Anciano , Mama/patología , Mama/cirugía , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Bases de Datos Factuales/estadística & datos numéricos , Estudios de Factibilidad , Femenino , Mortalidad Hospitalaria , Humanos , Mamoplastia/métodos , Mastectomía Segmentaria/métodos , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Mejoramiento de la Calidad/estadística & datos numéricos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Operative approaches for Hinchey III diverticulitis include the Hartmann procedure, primary resection and anastomosis, and laparoscopic lavage. Several randomized controlled trials and meta-analyses have compared these approaches; however, results are conflicting and previous studies have not captured the complexity of balancing surgical risks and quality of life. OBJECTIVE: This study aimed to determine the optimal operative strategy for patients with Hinchey III sigmoid diverticulitis. DESIGN: We developed a Markov cohort model, incorporating perioperative morbidity/mortality, emergency and elective reoperations, and quality-of-life weights. We derived model parameters from systematic reviews and meta-analyses, where possible. We performed a second-order Monte Carlo probabilistic sensitivity analysis to account for joint uncertainty in model parameters. SETTING: This study measured outcomes over patients' lifetime horizon. PATIENTS: The base case was a simulated cohort of 65-year-old patients with Hinchey III diverticulitis. A scenario simulating a cohort of highly comorbid 80-year-old patients was also planned. INTERVENTIONS: Hartmann procedure, primary resection and anastomosis (with or without diverting ileostomy), and laparoscopic lavage were performed. MAIN OUTCOME MEASURES: Quality-adjusted life years were the primary outcome measured. RESULTS: Following surgery for Hinchey III diverticulitis, 39.5% of patients who underwent the Hartmann procedure, 14.3% of patients who underwent laparoscopic lavage, and 16.7% of patients who underwent primary resection and anastomosis had a stoma at 12 months. After applying quality-of-life weights, primary resection and anastomosis was the optimal operative strategy, yielding 18.0 quality-adjusted life years; laparoscopic lavage and the Hartmann procedure yielded 9.6 and 13.7 fewer quality-adjusted life months. A scenario analysis for elderly, highly comorbid patients could not be performed because of a lack of high-quality evidence to inform model parameters. LIMITATIONS: This model required assumptions about the long-term postoperative course of patients who underwent laparoscopic lavage because few long-term data for this group have been published. CONCLUSIONS: Although the Hartmann procedure is widely used for Hinchey III diverticulitis, when considering both surgical risks and quality of life, both laparoscopic lavage and primary resection and anastomosis provide greater quality-adjusted life years for patients with Hinchey III diverticulitis, and primary resection and anastomosis appears to be the optimal approach. See Video Abstract at http://links.lww.com/DCR/B223. ESTRATEGIA OPERATIVA ÓPTIMA EN DIVERTICULITIS HINCHEY III DE SIGMOIDES: UN ANÁLISIS DE DECISION: Los enfoques quirúrgicos para la diverticulitis Hinchey III incluyen el procedimiento de Hartmann, la resección primaria y anastomosis, y el lavado laparoscópico. Varios ensayos controlados aleatorios y metanálisis han comparado estos enfoques; sin embargo, los resultados son contradictorios y los estudios previos no han captado la complejidad de equilibrar los riesgos quirúrgicos y la calidad de vida.Determinar la estrategia operativa óptima para pacientes con diverticulitis Hinchey III de sigmoides.Desarrollamos un modelo de cohorte de Markov, incorporando morbilidad / mortalidad perioperatoria, reoperaciones electivas y de emergencia, y pesos de calidad de vida. Derivamos los parámetros del modelo de revisiones sistemáticas y metaanálisis, cuando fue posible. Realizamos un análisis de sensibilidad probabilístico Monte Carlo de segundo orden para tener en cuenta la incertidumbre conjunta en los parámetros del modelo.Seguimiento de por vida.El caso base fue una cohorte simulada de pacientes de 65 años con diverticulitis de Hinchey III. También se planeó un escenario que simulaba una cohorte de pacientes de 80 años altamente comórbidos.Procedimiento de Hartmann, resección primaria y anastomosis (con o sin desviación de ileostomía) y lavado laparoscópico.Años de vida ajustados por calidad.Después de la cirugía para la diverticulitis de Hinchey III, el 39.5% de los pacientes que se sometieron al procedimiento de Hartmann, el 14.3% de los pacientes que se sometieron a un lavado laparoscópico, y el 16.7% de los pacientes que se sometieron a resección primaria y anastomosis tuvieron un estoma a los 12 meses. Después de aplicar el peso de la calidad de vida, la resección primaria y la anastomosis fueron la estrategia operativa óptima, que dio como resultado 18.0 años de vida ajustados en función de la calidad; el lavado laparoscópico y el procedimiento de Hartmann arrojaron 9.6 y 13.7 meses de vida ajustados en función de la calidad, respectivamente. No se pudo realizar un análisis de escenarios para pacientes de edad avanzada altamente comórbidos debido a la falta de evidencia de alta calidad para informar los parámetros del modelo.Este modelo requirió suposiciones sobre el curso postoperatorio a largo plazo de pacientes que se sometieron a lavado laparoscópico, ya que se han publicado pocos datos a largo plazo para este grupo.Aunque el procedimiento de Hartmann se usa ampliamente para la diverticulitis de Hinchey III, cuando se consideran tanto los riesgos quirúrgicos como la calidad de vida, tanto el lavado laparoscópico como la resección primaria y la anastomosis proporcionan una mayor calidad de años de vida ajustada para los pacientes con diverticulitis de Hinchey III y la resección primaria y anastomosis parece ser el enfoque óptimo. Consulte Video Resumen en http://links.lww.com/DCR/B223.
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Anastomosis Quirúrgica/estadística & datos numéricos , Diverticulitis/cirugía , Laparoscopía/estadística & datos numéricos , Enfermedades del Sigmoide/patología , Anciano , Anciano de 80 o más Años , Anastomosis Quirúrgica/métodos , Técnicas de Apoyo para la Decisión , Diverticulitis/clasificación , Diverticulitis/psicología , Procedimientos Quirúrgicos Electivos/métodos , Humanos , Laparoscopía/métodos , Metaanálisis como Asunto , Periodo Perioperatorio/mortalidad , Lavado Peritoneal/métodos , Periodo Posoperatorio , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Reoperación/estadística & datos numéricos , Medición de RiesgoRESUMEN
PURPOSE: Several randomized controlled trials (RCTs) have investigated observation or axillary radiotherapy (ART) in place of completion axillary lymph node dissection (cALND) for management of positive sentinel nodes (SNs) in clinically node-negative women with breast cancer. The optimal treatment strategy for this population is not known. METHODS: MEDLINE, Embase, and EBM Reviews-NHS Economic Evaluation Database were searched from inception until July 2019. A systematic review and narrative summary was performed of RCTs comparing observation or ART versus cALND in clinically node-negative female breast cancer patients with positive SNs. The Cochrane risk of bias tool for RCTs was used to assess risk of bias. Outcomes of interest included overall survival (OS), disease-free survival (DFS), axillary recurrence, and axillary surgery-related morbidity. RESULTS: Three trials compared observation with cALND, and two trials compared ART with cALND. No studies blinded participants or personnel, and there was heterogeneity in inclusion criteria, study design, and follow-up. Neither observation nor ART resulted in statistically inferior 5- or 8-year OS or DFS compared with cALND. There was also no statistically significant increase in axillary recurrences associated with either approach. Four trials reported morbidity outcomes, and all showed cALND was associated with significantly more lymphedema, paresthesia, and shoulder dysfunction compared with observation or ART. CONCLUSIONS: Women with clinically node-negative breast cancer and positive SNs can safely be managed without cALND.
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Neoplasias de la Mama , Ganglio Linfático Centinela , Espera Vigilante , Axila , Neoplasias de la Mama/patología , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Femenino , Humanos , Escisión del Ganglio Linfático , Ganglios Linfáticos/cirugía , Metástasis Linfática , Ensayos Clínicos Controlados Aleatorios como Asunto , Ganglio Linfático Centinela/cirugía , Biopsia del Ganglio Linfático CentinelaRESUMEN
BACKGROUND AND AIMS: Propofol is increasingly being used for sedation in colonoscopy; however, its benefits over midazolam (± short-acting opioids) are not well quantified. The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus midazolam (± short-acting opioids) in patients undergoing colonoscopy. METHODS: We systematically searched Medline, Embase, and the Cochrane library (to July 30, 2018) for randomized controlled trials of colonoscopies performed with propofol versus midazolam (± short-acting opioids). We pooled odds ratios for cardiorespiratory outcomes using mixed-effects conditional logistic models. We pooled standardized mean differences (SMDs) for patient and endoscopist satisfaction and efficiency outcomes using random-effects models. RESULTS: Nine studies of 1427 patients met the inclusion criteria. There were no significant differences in cardiorespiratory outcomes (hypotension, hypoxia, bradycardia) between sedative groups. Patient satisfaction was high in both groups, with most patients reporting willingness to undergo a future colonoscopy with the same sedative regimen. In the meta-analysis, patients sedated with propofol had greater satisfaction than those sedated with midazolam (± short-acting opioids) (SMD, .54; 95% confidence interval [CI], .30-.79); however, there was considerable heterogeneity. Procedure time was similar between groups (SMD, .15; 95% CI, .04-.27), but recovery time was shorter in the propofol group (SMD, .41; 95% CI, .08-.74). The median difference in recovery time was 3 minutes, 6 seconds shorter in patients sedated with propofol. CONCLUSIONS: Both propofol and midazolam (± short-acting opioids) result in high patient satisfaction and appear to be safe for use in colonoscopy. The marginal benefits to propofol are small improvements in satisfaction and recovery time.