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BACKGROUND: We conducted a systematic review and meta-analysis to evaluate the role of High Energy Devices (HEDs) versus conventional clamp and tie technique in thyroidectomy. This work is endorsed by the Italian Society of Surgical Endoscopy (Italian Society of Endoscopic Surgery and new technologies-SICE) in the broader project on the evaluation of the role of HEDs in different surgical settings with the full health technology assessment report. MEHODS: Inclusion criteria were adult patients (≥ 18 years old) undergoing Thyroidectomy/Parathyroidectomy conducted with High Energy Devices (as ultrasonic (US), radiofrequency (RF), and hybrid energy (H-US/RF)) in the setting of thyroid surgery (both partial and total) for benign and malign diseases. However, some variability was found in included studies and described in the text. This systematic review and meta-analysis were performed according to the Cochrane handbook for systematic reviews, and the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines were pursuit. Selection of abstracts was performed in Ryyan system by 2 independent reviewers, and doubts were solved by another independent reviewer. At the end of literature research, Randomized controlled trials and observational studies were included. Risk of Bias was assessed with ROB2 for RCTs, and New Castle Ottawa Scale for Observational studies. RESULTS: The literature search yielded 47 studies, including 29 RCTs and 18 observational studies. Meta-analysis was performed for 29 randomized clinical trials. Outcomes included in the comparison between High Energy Devise and conventional technique groups were operative time, operative blood loss, overall post-operative drainage volume, length of stay, complications, and costs. HED significantly reduced operative time (28 studies, 3097patients; MD -128.8; 95% CI -34.4 to -23.20; I2 = 96%, p < 0.00001, Random-effect), intra-operative blood loss (13 studies, 642 vs 519 patients; SMD -0.82; 95% CI -1.33 to -0.32; I2 = 93%, p < 0.00001, Random-effect), LOS (22 studies, 2808 vs 2789 patients; MD -0.38, 95% CI -0.59 to -0.17; I2 = 98%, p < 0.00001 Random-effect), and healthcare costs (8 studies, 1138 vs 1129 patients, SMD 1.05; 95% CI -0.06 to 2.16; I2 = 99%, p < 0.00001 Random-effect). The rate of overall intraoperative complications was significantly different between both groups (25 studies, 2804 vs 2775 patients; RR 0.88, 95% CI 0.80 to 0.97; I2 = 38%, p = 0.03 Random-effect), but the sensitivity analysis did not find a statistically significant difference (6 studies, 605 vs 594 patients, RR; 95% CI to; I2 = 0%, p = 0.50, Random-effect). There was no difference in the subgroup analysis for the occurrence of transient and permanent RLN palsy, nor hematoma formation and hypocalcaemia. DISCUSSION: Though findings of our systematic review and metanalysis are limited by heterogeneous data, surgeons, hospital managers, and policymakers should note that the use of High Energy Devices compared to conventional clamp and tie technique have reduced operative times, intra-operative blood loss, length of stay, and hospital costs in patients underwent to tyroid surgery. Future work must explore issues of equity to mitigate barriers to patient access to safe thyroid surgical care and define better this initial results.
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Tireoidectomia , Humanos , Tireoidectomia/métodos , Tireoidectomia/efeitos adversos , Tireoidectomia/instrumentação , Doenças da Glândula Tireoide/cirurgia , Paratireoidectomia/métodosRESUMO
INTRODUCTION: According to the literature, there is no clear definition of a High Energy Devices (HEDs), and their proper indications for use are also unclear. Nevertheless, the flourishing market of HEDs could make their choice in daily clinical practice arduous, possibly increasing the risk of improper use for a lack of specific training. At the same time, the diffusion of HEDs impacts the economic asset of the healthcare systems. This study aims to assess the efficacy and safety of HEDs compared to electrocautery devices while performing laparoscopic cholecystectomy (LC). MATERIALS AND METHODS: On behalf of the Italian Society of Endoscopic Surgery and New Technologies, experts performed a systematic review and meta-analysis and synthesised the evidence assessing the efficacy and safety of HEDs compared to electrocautery devices while performing laparoscopic cholecystectomy (LC). Only randomised controlled trials (RCTs) and comparative observational studies were included. Outcomes were: operating time, bleeding, intra-operative and post-operative complications, length of hospital stay, costs, and exposition to surgical smoke. The review was registered on PROSPERO (CRD42021250447). RESULTS: Twenty-six studies were included: 21 RCTs, one prospective parallel arm comparative non-RCT, and one retrospective cohort study, while three were prospective comparative studies. Most of the studies included laparoscopic cholecystectomy performed in an elective setting. All the studies but three analysed the outcomes deriving from the utilisation of US sources of energy compared to electrocautery. Operative time was significantly shorter in the HED group compared to the electrocautery group (15 studies, 1938 patients; SMD - 1.33; 95% CI - 1.89 to 0.78; I2 = 97%, Random-effect). No other statistically significant differences were found in the other examined variables. CONCLUSIONS: HEDs seem to have a superiority over Electrocautery while performing LC in terms of operative time, while no difference was observed in terms of length of hospitalisation and blood loss. No concerns about safety were raised.
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Colecistectomia Laparoscópica , Laparoscopia , Humanos , Hospitalização , Tempo de Internação , Complicações Pós-Operatórias , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The present paper aims at evaluating the potential benefits of high-energy devices (HEDs) in the Italian surgical practice, defining the comparative efficacy and safety profiles, as well as the potential economic and organizational advantages for hospitals and patients, with respect to standard monopolar or bipolar devices. METHODS: A Health Technology Assessment was conducted in 2021 assuming the hospital perspective, comparing HEDs and standard monopolar/bipolar devices, within eleven surgical settings: appendectomy, hepatic resections, colorectal resections, cholecystectomy, splenectomy, hemorrhoidectomy, thyroidectomy, esophago-gastrectomy, breast surgery, adrenalectomy, and pancreatectomy. The nine EUnetHTA Core Model dimensions were deployed considering a multi-methods approach. Both qualitative and quantitative methods were used: (1) a systematic literature review for the definition of the comparative efficacy and safety data; (2) administration of qualitative questionnaires, completed by 23 healthcare professionals (according to 7-item Likert scale, ranging from - 3 to + 3); and (3) health-economics tools, useful for the economic evaluation of the clinical pathway and budget impact analysis, and for the definition of the organizational and accessibility advantages, in terms of time or procedures' savings. RESULTS: The literature declared a decrease in operating time and length of stay in using HEDs in most surgical settings. While HEDs would lead to a marginal investment for the conduction of 178,619 surgeries on annual basis, their routinely implementation would generate significant organizational savings. A decrease equal to - 5.25/-9.02% of operating room time and to - 5.03/-30.73% of length of stay emerged. An advantage in accessibility to surgery could be hypothesized in a 9% of increase, due to the gaining in operatory slots. Professionals' perceptions crystallized and confirmed literature evidence, declaring a better safety and effectiveness profile. An improvement in both patients and caregivers' quality-of-life emerged. CONCLUSIONS: The results have demonstrated the strategic relevance related to HEDs introduction, their economic sustainability, and feasibility, as well as the potentialities in process improvement.
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Hospitais , Avaliação da Tecnologia Biomédica , Humanos , Avaliação da Tecnologia Biomédica/métodos , Itália , Pancreatectomia , Análise Custo-BenefícioRESUMO
BACKGROUND: genetic testing for cystic fibrosis (CF) has been offered to people with higher risk of being carrier. OBJECTIVES: to assess the effectiveness of population-based CF carrier screening for adults of reproductive age and its optimal organizational features. DESIGN: systematic review. SETTING AND PARTICIPANTS: MedLine, Embase, Cochrane Library, CINAHL and LILACS (1990-2022) were searched to retrieve primary and secondary studies on adults (16 years and older), with no clinical indication or genetic risk, eligible for genetic testing for CF carrier status. MAIN OUTCOMES MEASURES: attitude to screening, uptake of screening offered, informed reproductive choices. RESULTS: a total of 3,326 records were screened and 292 potentially eligible full-text publications assessed. The review included 71 publications, corresponding to 3 reviews, 40 cohort studies (11 comparative, 29 single-arm), and 6 model studies, published between 1992 and 2021 (median 1998). Only one study compared screening or no screening. This study suggested an association between carrier screening and a lower incidence of CF. Comparative studies examined different approaches for invitation and testing, i.e., settings, target population (individuals/couples, prenatal/preconceptional), how invitations are organized (primary care/maternal hospitals), and format and content of the pre-test information. However, no firm conclusions can be drawn on the impact of these features on informed reproductive choices, uptake, and attitude, because of the limitations of the evidence collected. CONCLUSIONS: the broad heterogeneity of the studies, methodological weaknesses, and the limited transferability of the results mean there is still uncertainty about the effectiveness of preconceptional and prenatal CF carrier screening in the general population.
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Fibrose Cística , Gravidez , Feminino , Adulto , Humanos , Triagem de Portadores Genéticos/métodos , Fibrose Cística/diagnóstico , Fibrose Cística/epidemiologia , Fibrose Cística/genética , Itália , Testes Genéticos/métodos , Fatores de RiscoRESUMO
PURPOSE: We performed a systematic review and meta-analysis with trial sequential analysis (TSA) to answer whether early closure of defunctioning ileostomy may be suitable after low anterior resection. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, up to October 2021, for RCTs comparing early closure (EC ≤ 30 days) and delayed closure (DC ≥ 60 days) of defunctioning ileostomy. The risk ratio (RR) with 95% CI was calculated for dichotomous variables and the mean difference (MD) with 95% CI for continuous variables. The GRADE methodology was implemented for assessing Quality of Evidence (QoE). TSA was implemented to address the risk of random error associated with sparse data and/or multiple testing. RESULTS: Seven RCTs were included for quantitative synthesis. 599 patients were allocated to either EC (n = 306) or DC (n = 293). EC was associated with a higher rate of wound complications compared to DC (RR 2.56; 95% CI 1.33 to 4.93; P = 0.005; I2 = 0%, QoE High), a lower incidence of postoperative small bowel obstruction (RR 0.46; 95% CI 0.24 to 0.89; P = 0.02; I2 = 0%, QoE moderate), and a lower rate of stoma-related complications (RR 0.26; 95% CI 0.16 to 0.42; P < 0.00001; I2 = 0%, QoE moderate). The rate of minor low anterior resection syndrome (LARS) (RR 1.13; 95% CI 0.55 to 2.33; P = 0.74; I2 = 0%, QoE low) and major LARS (RR 0.80; 95% CI 0.59 to 1.09; P = 0.16; I2 = 0%, QoE low) did not differ between the two groups. TSA demonstrated inconclusive evidence with insufficient sample sizes to detect the observed effects. CONCLUSION: EC may confer some advantages compared with a DC. However, TSA advocated a cautious interpretation of the results. PROSPERO REGISTER ID: CRD42021276557.
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Neoplasias Retais , Estomas Cirúrgicos , Humanos , Ileostomia/efeitos adversos , Complicações Pós-Operatórias/etiologia , Neoplasias Retais/complicações , Neoplasias Retais/cirurgia , SíndromeRESUMO
PURPOSE: To review the marketing authorization of biosimilars and provide a critical analysis of the pivotal trials supporting their approval by the European Medicines Agency (EMA). METHODS: EMA website to identify the biosimilars approved up to July 2019 and the European Public Assessment Report for information on pivotal trial design, duration, intervention and control, primary outcome, data on immunogenicity, and comparability margins. RESULTS: The EMA has approved 55 biosimilars (62% in 2017-2019) of 16 biologic products, used in several clinical indications. Some biosimilars were licensed as multiple products, with different commercial names, by the same or different companies. The comparability exercise and subsequent approval of 49/55 (89%) biosimilars were based on one or more pivotal phase III trials testing their clinical efficacy. In all, biosimilars were approved on the basis of 55 trials, mostly phase III (42/55, 76%) assessing clinical efficacy; these were mainly equivalence trials (31/55, 56%). The pivotal phase III trials assessed surrogate measures of clinical effect, and 71% reported immunogenicity data. CONCLUSION: Analysis of the approval of biosimilars in Europe depicts a complex and heterogeneous scenario. The requirement for showing similarity in terms of clinical efficacy and safety provides a robust demonstration of comparable clinical outcomes but lays a burden on biosimilar manufacturers and may delay the introduction of the drugs. The development, licensing, and monitoring of biosimilars would benefit from new strategies to accelerate access to these drugs while reducing uncertainties about their use in practice.
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Medicamentos Biossimilares/uso terapêutico , Ensaios Clínicos como Assunto , Aprovação de Drogas , Regulamentação Governamental , Marketing/legislação & jurisprudência , Medicamentos Biossimilares/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Bases de Dados Factuais , Aprovação de Drogas/economia , Aprovação de Drogas/legislação & jurisprudência , Indústria Farmacêutica , Europa (Continente) , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Although several non-randomized studies comparing robotic pancreaticoduodenectomy (RPD) and open pancreaticoduodenectomy (OPD) recently demonstrated that the two operative techniques could be equivalent in terms of safety outcomes and short-term oncologic efficacy, no definitive answer has arrived yet to the question as to whether robotic assistance can contribute to reducing the high rate of postoperative morbidity. METHODS: Systematic literature search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE databases. Prospective and retrospective studies comparing RPD and OPD as surgical treatment for periampullary benign and malignant lesions were included in the systematic review and meta-analysis with no limits of language or year of publication. RESULTS: 18 non-randomized studies were included for quantitative synthesis with 13,639 patients allocated to RPD (n = 1593) or OPD (n = 12,046). RPD and OPD showed equivalent results in terms of mortality (3.3% vs 2.8%; P = 0.84), morbidity (64.4% vs 68.1%; P = 0.12), pancreatic fistula (17.9% vs 15.9%; P = 0.81), delayed gastric emptying (16.8% vs 16.1%; P = 0.98), hemorrhage (11% vs 14.6%; P = 0.43), and bile leak (5.1% vs 3.5%; P = 0.35). Estimated intra-operative blood loss was significantly lower in the RPD group (352.1 ± 174.1 vs 588.4 ± 219.4; P = 0.0003), whereas operative time was significantly longer for RPD compared to OPD (461.1 ± 84 vs 384.2 ± 73.8; P = 0.0004). RPD and OPD showed equivalent results in terms of retrieved lymph nodes (19.1 ± 9.9 vs 17.3 ± 9.9; P = 0.22) and positive margin status (13.3% vs 16.1%; P = 0.32). CONCLUSIONS: RPD is safe and feasible as surgical treatment for malignant or benign disease of the pancreatic head and the periampullary region. Equivalency in terms of surgical radicality including R0 curative resection and number of harvested lymph nodes between the two groups confirmed the reliability of RPD from an oncologic point of view.
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Ampola Hepatopancreática , Neoplasias do Ducto Colédoco/cirurgia , Pancreaticoduodenectomia/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Humanos , Duração da CirurgiaRESUMO
BACKGROUND: Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated. METHODS: In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6 ≥ 30% as unacceptable. RESULTS: BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%). CONCLUSIONS: BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity. CLINICAL TRIAL REGISTRATION: NCT01735071 (Clinicaltrials.gov).
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Epitelial do Ovário/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bevacizumab/administração & dosagem , Bevacizumab/efeitos adversos , Carboplatina/administração & dosagem , Carboplatina/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Intervalo Livre de Progressão , Taxa de Sobrevida , Trabectedina/administração & dosagem , Trabectedina/efeitos adversosRESUMO
OBJECTIVE: The aim of this meta-analysis was to summarize the current available evidence on nonoperative management (NOM) with antibiotics for uncomplicated appendicitis, both in adults and children. SUMMARY BACKGROUND DATA: Although earlier meta-analyses demonstrated that NOM with antibiotics may be an acceptable treatment strategy for patients with uncomplicated appendicitis, evidence is limited by conflicting results. METHODS: Systematic literature search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE databases for randomized and nonrandomized studies comparing antibiotic therapy (AT) and surgical therapy-appendectomy (ST) for uncomplicated appendicitis. Literature search was completed in August 2018. RESULTS: Twenty studies comparing AT and ST qualified for inclusion in the quantitative synthesis. In total, 3618 patients were allocated to AT (n = 1743) or ST (n = 1875). Higher complication-free treatment success rate (82.3% vs 67.2%; P < 0.00001) and treatment efficacy based on 1-year follow-up rate (93.1% vs 72.6%; P < 0.00001) were reported for ST. Index admission antibiotic treatment failure and rate of recurrence at 1-year follow-up were reported in 8.5% and 19.2% of patients treated with antibiotics, respectively. Rates of complicated appendicitis with peritonitis identified at the time of surgical operation (AT: 21.7% vs ST: 12.8%; P = 0.07) and surgical complications (AT: 12.8% vs ST: 13.6%; P = 0.66) were equivalent. CONCLUSIONS: Antibiotic therapy could represent a feasible treatment option for image-proven uncomplicated appendicitis, although complication-free treatment success rates are higher with ST. There is also evidence that NOM for uncomplicated appendicitis does not statistically increase the perforation rate in adult and pediatric patients receiving antibiotic treatment. NOM with antibiotics may fail during the primary hospitalization in about 8% of cases, and an additional 20% of patients might need a second hospitalization for recurrent appendicitis.
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Antibacterianos/uso terapêutico , Apendicectomia , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Adulto , Criança , HumanosRESUMO
OBJECTIVE: The anastomotic leak rate in colorectal surgery is highest in patients receiving anterior rectal resections. The placement of prophylactic pelvic drains remains a routine option for preventing postoperative leaks, despite increasing evidence suggesting no clinical benefit. The present study seeks to identify a consensus on the use of prophylactic drains in anterior rectal resections. METHODS: A systematic search was conducted of MEDLINE, Scopus, EMBASE, and Cochrane Library databases to identify clinical trials comparing the use of drainage to non-drainage in cases of colorectal anastomosis. RESULTS: Three randomized clinical trials (RCTs) and two controlled clinical trials (CCTs) were identified that met the inclusion criteria, with a total of 1702 patients with rectal cancer who underwent anterior resection: 1206 with a pelvic drain and 496 without a pelvic drain. Meta-analysis showed that the use of a drain did not significantly improve the outcomes of anastomotic leaks; the overall reoperation rate during the 30-day postoperative period and the postoperative mortality were statistically lower in the drained group (OR 2.82, 95% CI 1.33 to 5.97; I2 = 0%). CONCLUSIONS: The use of prophylactic pelvic drainage after anterior rectal resections does not provide significant benefits with respect to anastomotic leaks and overall complication rates. However, an approximately threefold reduction of the postoperative mortality of the drained patients was observed. Given the limitations of the present study, these findings warrant the use of a drain after anterior rectal resection. Nevertheless, due to the low quality of the available data, further multicenter trials with uniform inclusion criteria are needed to evaluate drain usage in the anterior rectal resection.
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Procedimentos Cirúrgicos do Sistema Digestório , Drenagem , Reto/cirurgia , Anastomose Cirúrgica/efeitos adversos , Fístula Anastomótica/etiologia , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Humanos , Incidência , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Viés de Publicação , ReoperaçãoRESUMO
BACKGROUND: Injuries to the recurrent inferior laryngeal nerve (RILN) remain one of the major post-operative complications after thyroid and parathyroid surgery. Damage to this nerve can result in a temporary or permanent palsy, which is associated with vocal cord paresis or paralysis. Visual identification of the RILN is a common procedure to prevent nerve injury during thyroid and parathyroid surgery. Recently, intraoperative neuromonitoring (IONM) has been introduced in order to facilitate the localisation of the nerves and to prevent their injury during surgery. IONM permits nerve identification using an electrode, where, in order to measure the nerve response, the electric field is converted to an acoustic signal. OBJECTIVES: To assess the effects of IONM versus visual nerve identification for the prevention of RILN injury in adults undergoing thyroid surgery. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 21 August 2018. We did not apply any language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing IONM nerve identification plus visual nerve identification versus visual nerve identification alone for prevention of RILN injury in adults undergoing thyroid surgery DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts for relevance. One review author carried out screening for inclusion, data extraction and 'Risk of bias' assessment and a second review author checked them. For dichotomous outcomes, we calculated risk ratios (RRs) with 95% confidence intervals (CIs). For continuous outcomes, we calculated mean differences (MDs) with 95% CIs. We assessed trials for certainty of the evidence using the GRADE instrument. MAIN RESULTS: Five RCTs with 1558 participants (781 participants were randomly assigned to IONM and 777 to visual nerve identification only) met the inclusion criteria; two trials were performed in Poland and one trial each was performed in China, Korea and Turkey. Inclusion and exclusion criteria differed among trials: previous thyroid or parathyroid surgery was an exclusion criterion in three trials. In contrast, this was a specific inclusion criterion in another trial. Three trials had central neck compartment dissection or lateral neck dissection and Graves' disease as exclusion criteria. The mean duration of follow-up ranged from 6 to 12 months. The mean age of participants ranged between 41.7 years and 51.9 years.There was no firm evidence of an advantage or disadvantage comparing IONM with visual nerve identification only for permanent RILN palsy (RR 0.77, 95% CI 0.33 to 1.77; P = 0.54; 4 trials; 2895 nerves at risk; very low-certainty evidence) or transient RILN palsy (RR 0.62, 95% CI 0.35 to 1.08; P = 0.09; 4 trials; 2895 nerves at risk; very low-certainty evidence). None of the trials reported health-related quality of life. Transient hypoparathyroidism as an adverse event was not substantially different between intervention and comparator groups (RR 1.25; 95% CI 0.45 to 3.47; P = 0.66; 2 trials; 286 participants; very low-certainty evidence). Operative time was comparable between IONM and visual nerve monitoring alone (MD 5.5 minutes, 95% CI -0.7 to 11.8; P = 0.08; 3 trials; 1251 participants; very low-certainty evidence). Three of five included trials provided data on all-cause mortality: no deaths were reported. None of the trials reported socioeconomic effects. The evidence reported in this review was mostly of very low certainty, particularly because of risk of bias, a high degree of imprecision due to wide confidence intervals and substantial between-study heterogeneity. AUTHORS' CONCLUSIONS: Results from this systematic review and meta-analysis indicate that there is currently no conclusive evidence for the superiority or inferiority of IONM over visual nerve identification only on any of the outcomes measured. Well-designed, executed, analysed and reported RCTs with a larger number of participants and longer follow-up, employing the latest IONM technology and applying new surgical techniques are needed.
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Monitorização Neurofisiológica Intraoperatória , Traumatismos do Nervo Laríngeo Recorrente/prevenção & controle , Nervo Laríngeo Recorrente/fisiologia , Glândula Tireoide/cirurgia , Tireoidectomia/efeitos adversos , Adulto , Humanos , Duração da Cirurgia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Three-dimensional view in laparoscopic general, gynaecologic and urologic surgery is an efficient, safe and sustainable innovation. The present paper is an extract taken from a full health technology assessment report on three-dimensional vision technology compared with standard two-dimensional laparoscopic systems. METHODS: A health technology assessment approach was implemented in order to investigate all the economic, social, ethical and organisational implications related to the adoption of the innovative three-dimensional view. With the support of a multi-disciplinary team, composed of eight experts working in Italian hospitals and Universities, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaire and self-reported interviews, applying a final MCDA quantitative approach, and considering the dimensions resulting from the EUnetHTA Core Model. RESULTS: From systematic search of literature, we retrieved the following studies: 9 on general surgery, 35 on gynaecology and urology, both concerning clinical setting. Considering simulated setting we included: 8 studies regarding pitfalls and drawbacks, 44 on teaching, 12 on surgeons' confidence and comfort and 34 on surgeons' performances. Three-dimensional laparoscopy was shown to have advantages for both the patients and the surgeons, and is confirmed to be a safe, efficacious and sustainable vision technology. CONCLUSIONS: The objective of the present paper, under the patronage of Italian Society of Endoscopic Surgery, was achieved in that there has now been produced a scientific report, based on a HTA approach, that may be placed in the hands of surgeons and used to support the decision-making process of the health providers.
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Imageamento Tridimensional , Laparoscopia/métodos , Custos e Análise de Custo , Percepção de Profundidade , Humanos , Imageamento Tridimensional/economia , Itália , Laparoscopia/economia , Duração da Cirurgia , Segurança do Paciente , Complicações Pós-Operatórias , Desempenho Psicomotor , Avaliação da Tecnologia BiomédicaRESUMO
OBJECTIVE: Neoadjuvant chemotherapy (NACT) is a valid treatment option for women with locally advanced cervical cancer (LACC). This study aims to evaluate the impact of sociodemographic factors, clinical factors, and NACT regimens on survival endpoints. The role of pathological response to NACT as a surrogate endpoint of survival was also assessed. MATERIALS AND METHODS: Retrospective analysis of consecutive sample data from women with LACC (stages Ib2-IVa) who underwent NACT followed by radical surgery was performed. Response was classified as optimal response (including complete response and optimal partial response), suboptimal partial response, stable disease, and progressive disease. RESULTS: Four hundred forty-six women who had undergone surgery from 1992 to 2011 were analyzed. The overall optimal response was 35.4%. At a median follow-up of 12.7 years, 165 women (37.0%) experienced recurrence or died. Increase in patient age at surgery, International Federation of Gynecology and Obstetrics stage III/IV versus stage Ib2, and lymph-node positivity versus negativity seemed to impact negatively on survival, whereas neoadjuvant platinum-Taxol-containing regimens (compared with platinum-based regimens) improved survival. Response to NACT could be considered a surrogate endpoint of survival. CONCLUSIONS: Age, International Federation of Gynecology and Obstetrics stage III/IV, lymph-node involvement, and type of NACT administered have a significant impact on survival. Response to NACT is a good surrogate endpoint of survival in patients with LACC.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia Neoadjuvante , Neoplasias do Colo do Útero/tratamento farmacológico , Neoplasias do Colo do Útero/mortalidade , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/mortalidade , Adolescente , Adulto , Idoso , Biomarcadores , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/mortalidade , Quimioterapia Adjuvante , Cisplatino/administração & dosagem , Doxorrubicina/administração & dosagem , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Invasividade Neoplásica , Estadiamento de Neoplasias , Paclitaxel/administração & dosagem , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida , Fatores de Tempo , Adulto JovemRESUMO
This project of Health technology assessment was aimed at defining the impacts of offering a cystic fibrosis (CF) carrier screening to the general population, compared to the current situation, where the test is offered to individuals at high-risk to give birth to a child with CF. Results revealed: i) a lack of robust and updated data; ii) a return on investment up to six years from the screening's introduction, despite important economic and organizational efforts; iii) a general positive attitude of healthcare professionals, people with CF, families and general population; iv) possible issues related to the social impact.
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Fibrose Cística , Triagem de Portadores Genéticos , Humanos , Fibrose Cística/diagnóstico , Fibrose Cística/genética , Triagem de Portadores Genéticos/métodos , Testes Genéticos , Pessoal de Saúde , Avaliação da Tecnologia BiomédicaRESUMO
In the past decade, significant European calls for research proposals have supported translational collaborative research on non-communicable and infectious diseases within the biomedical life sciences by bringing together interdisciplinary and multinational consortia. This research has advanced our understanding of disease pathophysiology, marking considerable scientific progress. Yet, it is crucial to retrospectively evaluate these efforts' societal impact. Research proposals should be thoughtfully designed to ensure that the research findings can be effectively translated into actionable policies. In addition, the choice of scientific methods plays a pivotal role in shaping the societal impact of research discoveries. Understanding the factors responsible for current unmet public health issues and medical needs is crucial for crafting innovative strategies for research policy interventions. A multistakeholder survey and a roundtable helped identify potential needs for consideration in the EU research and policy agenda. Based on survey findings, mental health disorders, metabolic syndrome, cancer, antimicrobial resistance, environmental pollution, and cardiovascular diseases were considered the public health challenges deserving prioritisation. In addition, early diagnosis, primary prevention, the impact of environmental pollution on disease onset and personalised medicine approaches were the most selected unmet medical needs. Survey findings enabled the formulation of some research-policies interventions (RPIs), which were further discussed during a multistakeholder online roundtable. The discussion underscored recent EU-level activities aligned with the survey-derived RPIs and facilitated an exchange of perspectives on public health and biomedical research topics ripe for interdisciplinary collaboration and warranting attention within the EU's research and policy agenda. Actionable recommendations aimed at facilitating the translation of knowledge into transformative, science-based policies are also provided.
Assuntos
União Europeia , Saúde Pública , Humanos , Inquéritos e Questionários , Política de Saúde , Participação dos Interessados , Necessidades e Demandas de Serviços de SaúdeRESUMO
BACKGROUND: The increase of lymphoma patient survival led to a modification of the incidence of long-term sequelae, including second malignancies (SM). Several groups have dealt with the incidence of SM, according to the primary treatment; however, a standardized approach for the early detection and screening of SM in the population of lymphoma survivors should be implemented. METHODS: A systematic review was conducted by Fondazione Italiana Linfomi (FIL), in order to define the incidence of SM, the impact of modern radiotherapy on SM risk, and the usefulness of tailored follow-up and screening strategies for early diagnosis of SM. Classical Hodgkin lymphoma (cHL) and diffuse large B-cell lymphoma (DLBCL) survivors were investigated. The MEDLINE, Embase, and Cochrane Library databases were checked for relevant reports published up to January 2020. The selection process was reported according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. RESULTS: A total of 27 full-text manuscripts resulted as eligible for the analysis. The incidence of SM in cHL patients treated with ABVD was higher compared to the general population and was even higher in patients treated with intensified regimens. The risk increased over time, as well as after 10-15 years from therapy, and was augmented by radiotherapy exposure. In DLBCL, more intensive regimens (i.e., R-CHOEP or R-MegaCHOEP) vs. R-CHOP were associated with a higher SM incidence. Salvage chemotherapy and autologous stem cell transplants increased the risk of SM in both cHL and DLBCL cohorts. A lower incidence of SM, particularly of breast cancer (BC), was shown in cohorts of cHL survivors treated with reduced radiation volumes and doses (involved fields vs. extended fields), but robust trials are still lacking. Considering the advantage of a structured screening for early detection of SM, all the included studies regarded cHL survivors and screening strategy for early BC detection. Moreover, the authors discuss additional papers, to guide the early diagnosis of lung, colorectal, skin, and thyroid cancer in patients at risk due to family history, drug or RT exposure, or unhealthy lifestyles. These screening strategies all passed through patient awareness. CONCLUSION: A modern approach to chemotherapy and radiotherapy led to a lower risk of SM, which should be confirmed over time. Early detection of secondary cancers could be achieved through a tailored screening program, according to the individual risk profile.
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The introduction of personalized medicine, through the increasing multi-omics characterization of disease, brings new challenges to disease modeling. The scope of this review was a broad evaluation of the relevance, validity, and predictive value of the current preclinical methodologies applied in stratified medicine approaches. Two case models were chosen: oncology and brain disorders. We conducted a scoping review, following the Joanna Briggs Institute guidelines, and searched PubMed, EMBASE, and relevant databases for reports describing preclinical models applied in personalized medicine approaches. A total of 1292 and 1516 records were identified from the oncology and brain disorders search, respectively. Quantitative and qualitative synthesis was performed on a final total of 63 oncology and 94 brain disorder studies. The complexity of personalized approaches highlights the need for more sophisticated biological systems to assess the integrated mechanisms of response. Despite the progress in developing innovative and complex preclinical model systems, the currently available methods need to be further developed and validated before their potential in personalized medicine endeavors can be realized. More importantly, we identified underlying gaps in preclinical research relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. To achieve a broad implementation of predictive translational models in personalized medicine, these fundamental deficits must be addressed.
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INTRODUCTION: Up to one-fifth of patients with colorectal cancer will develop peritoneal metastases, frequently without other districts' involvement. Despite the recent unsuccesses of hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer peritoneal metastases treatment, the rationale in the prophylactic setting remains strong. Several clinical and pharmacokinetic data suggest that the efficacy of intraperitoneal chemotherapy is highest when the disease is microscopic. However, robust evidence demonstrating whether the addition of HIPEC for high-risk colorectal cancers offers better control of local recurrence is lacking. METHODS AND ANALYSIS: This is a multicentre randomised phase 3 trial comparing prophylactic surgery plus HIPEC CO2 with mitomycin, over standard surgical excision in patients with colorectal cancer at high risk of peritoneal carcinomatosis; 388 patients will be included in this study. The primary objective is to compare the efficacy of prophylactic surgery (radical colorectal resection, omentectomy, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 with mitomycin and standard surgery in terms of local recurrence-free survival. The main secondary endpoints are disease-free survival (DFS), overall survival (OS) and safety. The primary endpoint will be described with a cumulative incidence function and will be analysed with Grey test to take account of the competing risks. DFS and OS will be described with the Kaplan-Meier method. ETHICS AND DISSEMINATION: This trial has been evaluated by the Italian Medicines Agency, local ethics committees and will be submitted to the Ministry of Health to notify the start of the trial according to the regulation of trials on devices with CE mark/certification.The results will be submitted for presentation at academic meetings and for publication in a peer-reviewed journal, whatever the findings. TRIAL REGISTRATION NUMBER: NCT03914820.