Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

OBJECTIVE: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. DESIGN: Meta-epidemiological study. DATA SOURCES: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. STUDY SELECTION: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. OUTCOME MEASURES: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. RESULTS: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). CONCLUSIONS: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. PROSPERO REGISTRATION NUMBER: CRD42019117364.

Impact of perioperative low-molecular-weight heparin therapy on clinical events of elderly patients with prior coronary stents implanted > 12 months undergoing non-cardiac surgery: a randomized, placebo-controlled trial.

BACKGROUND: Little is known about the safety and efficacy of discontinuing antiplatelet therapy via LMWH bridging therapy in elderly patients with coronary stents implanted for > 12 months undergoing non-cardiac surgery. This randomized trial was designed to compare the clinical benefits and risks of antiplatelet drug discontinuation via LMWH bridging therapy. METHODS: Patients were randomized 1:1 to receive subcutaneous injections of either dalteparin sodium or placebo. The primary efficacy endpoint was cardiac or cerebrovascular events. The primary safety endpoint was major bleeding. RESULTS: Among 2476 randomized patients, the variables (sex, age, body mass index, comorbidities, medications, and procedural characteristics) and percutaneous coronary intervention information were not significantly different between the bridging and non-bridging groups. During the follow-up period, the rate of the combined endpoint in the bridging group was significantly lower than in the non-bridging group (5.79% vs. 8.42%, p = 0.012). The incidence of myocardial injury in the bridging group was significantly lower than in the non-bridging group (3.14% vs. 5.19%, p = 0.011). Deep vein thrombosis occurred more frequently in the non-bridging group (1.21% vs. 0.4%, p = 0.024), and there was a trend toward a higher rate of pulmonary embolism (0.32% vs. 0.08%, p = 0.177). There was no significant difference between the groups in the rates of acute myocardial infarction (0.81% vs. 1.38%), cardiac death (0.24% vs. 0.41%), stroke (0.16% vs. 0.24%), or major bleeding (1.22% vs. 1.45%). Multivariable analysis showed that LMWH bridging, creatinine clearance < 30 mL/min, preoperative hemoglobin < 10 g/dL, and diabetes mellitus were independent predictors of ischemic events. LMWH bridging and a preoperative platelet count of < 70 × 109/L were independent predictors of minor bleeding events. CONCLUSIONS: This study showed the safety and efficacy of perioperative LMWH bridging therapy in elderly patients with coronary stents implanted > 12 months undergoing non-cardiac surgery. An alternative approach might be the use of bridging therapy with half-dose LMWH. TRIAL REGISTRATION: ISRCTN65203415.

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

Reducing axillary surgery in breast cancer / Reduciendo la cirugía axilar en el cáncer de mama

This article provides a brief account of the recent evolution of the highly controversial surgical management of the positive axilla in patients with breast cancer, an issue still open to disparate surgical procedures. This short review highlights the reports that supply the rationale for current trends in reducing the aggressiveness of this surgery and discusses the course of the trials still in progress pointing in the same direction, thus supporting the principle of not performing axillary lymph node dissection for staging purposes alone.(AU)

Este artículo es un breve resumen de la reciente evolución del controvertido tratamiento quirúrgico de la axila en pacientes con cáncer de mama, que sigue estando abierto a procedimientos quirúrgicos demasiado dispares. Esta corta revisión destaca las publicaciones que constituyen la base lógica de las tendencias actuales hacia la reducción de la agresividad quirúrgica y recalca los ensayos clínicos aún en progreso apuntando en esta misma dirección, apoyando así el principio de evitar la linfadenectomía axilar solo por razones de estadiaje.(AU)

Registro de actividades de la Sociedad Española de Angiología y Cirugía Vascular, año 2019 / Registry of activities of the Spanish Society of Angiology and Vascular Surgery, year 2019

Objetivo: describir la actividad asistencial del año 2019 de los servicios/unidades de angiología y cirugía vascular en España. Pacientes y métodos: estudio transversal con encuesta a 107 centros sobre procedimientos quirúrgicos y exploraciones vasculares realizados en 2019. Análisis descriptivo de resultados y comparación de la ratio de actividad /100 000 habitantes con 2018. Resultados: respondieron 44 servicios (41,1 %), 4 de ámbito privado. De los 42 servicios docentes, respondieron 29 (65,9 %), un 65,9 %. En los servicios que respondieron se produjeron 26 960 ingresos, el 46,4 % urgentes y el 53,5 % programados (estancia media: 6,8 días). En la mayoría de sectores no hubo cambios significativos en la ratio/100 000 habitantes, salvo un aumento moderado (10,7 frente a 9,4) en el sector distal, tanto en procedimientos quirúrgicos (3,3 frente a 2,8) como en endovasculares (7,3 frente a 6,6). Descenso moderado de procedimientos endovasculares en los troncos supraaórticos (1,4 frente a 1,6). Hubo una disminución moderada de procedimientos quirúrgicos en aorta torácica (0,17 frente a 0,20) y abdominal (2,38 frente a 2,78), que contrastó con un aumento moderado en procedimientos endovasculares abdominotorácicos (0,40 frente a 0,35). En las arterias viscerales se encontró una disminución relevante de procedimientos endovasculares (0,89 frente a 1,16) y un aumento moderado de los quirúrgicos (0,99 frente a 0,89). En el sector aortoilíaco hubo un aumento moderado de procedimientos endovasculares (6,8 frente a 5,8). En 2019 también se encontró una disminución relevante en el número de procedimientos endovasculares relacionados con los accesos de hemodiálisis (1,2 frente a 1,5), un descenso moderado en el número de amputaciones mayores (6,9 frente a 7,8) y un descenso relevante de actividad sobre las malformaciones (0,32 frente a 0,59). Se encontró un aumento moderado en la actividad global sobre el sector venoso con respecto a la de 2018 (93,3 vs. 80,3)...(AU)

Introduction and objective: to describe the healthcare activity of the Angiology and Vascular Surgery services/units in Spain in 2019.Patients and methods: cross-sectional study with a survey of 107 centers on surgical procedures and vascularexplorations performed in 2019. Descriptive analysis of results and comparison of the activity ratio / 100,000inhabitants with 2018.Results: 44 services responded (41.1 %), with only 4 being private. Of the 42 teaching services, 29 (65.9 %) respon-ded, representing 65.9 % of the total. In the services that responded, there were 26,960 admissions, 46.4 % urgentand 53.5% scheduled, with an average stay of 6.8 days. Global surgical activity in arterial surgery in 2019 was similarto that of 2018. In most sectors there were no significant changes in the ratio / 100,000 inhabitants, except for amoderate increase (10.7 vs. 9.4) in the distal sector , finding the increase in both surgical procedures (3.3 vs. 2.8) andendovascular procedures (7.3 vs. 6.6). Furthermore, a moderate decrease in endovascular procedures was foundin the supra-aortic trunks (1.4 vs. 1.6). There was a moderate decrease in surgical procedures in the thoracic aorta(0.17 vs. 0.20) and abdominal (2.38 vs. 2.78), which contrasted with a moderate increase in thoraco-abdominalendovascular procedures (0.40 vs. to 0.35). In visceral arteries, a relevant decrease in endovascular procedures wasfound (0.89 vs. 1.16) and a moderate increase in surgical procedures (0.99 vs. 0.89). In the aorto-iliac sector therewas a moderate increase in endovascular procedures (6.8 vs. 5.8). In 2019, a relevant decrease was also found inthe number of endovascular procedures related to hemodialysis accesses (1.2 vs. 1.5), and a moderate decreasein the number of major amputations (6.9 vs. 7.8)...(AU)

Fistula espontánea de LCR como manifestación de la hipertensión intracraneal idiopática / Spontaneous CSF fistula as manifestation of idiopathic intracranial hypertension

Introducción: La fistula espontanea de líquido cefalorraquídeo (LCR) de origen desconocido, es una afección poco frecuente cuya etiología se relaciona cada vez más con la hipertensión intracraneal idiopática (HII). Este estudio trata de concienciar que no deben considerase como 2 procesos distintos, sino que las fistulas pueden ser una forma de inicio, requiriendo un estudio y tratamiento posterior. Se describen las técnicas de reparación, así como el estudio de la HII. Resultados: Se trataron 8 pacientes, 5 mujeres y 3 varones, con edades comprendidas entre 46 y 72 años, con diagnóstico de fistula espontánea de LCR, 4 nasales y 4 óticas a los que se le sometió a tratamiento quirúrgico. Tras la reparación se realizó un estudio diagnóstico para la HII mediante RMN y angio-RM, presentando en todos los casos una estenosis de seno venoso transverso. Los valores de presión intracraneal obtenidos mediante punción lumbar mostraron valores de 20mmHg o superiores. Todos los pacientes fueron diagnosticados de HII. El seguimiento a un año no reveló ninguna recidiva de las fistulas, manteniendo un control de la HII. Conclusión: A pesar de su escasa frecuencia tanto de las fistulas craneales de LCR como de la HII, debe considerarse una asociación de ambas afecciones continuando el estudio y vigilancia de estos pacientes tras el cierre de la fístula.(AU)

Introduction: Spontaneous cerebrospinal fluid (CSF) fistula, of unknown origin, is a rare condition whose etiology is increasingly related to idiopathic intracranial hypertension (IIH). This study tries to raise awareness that they should not be considered as two different processes, but that fistulas can be a form of debut, requiring a study and subsequent treatment. Repair techniques are described, as well as the study of IIH. Results: We treated eight patients, five women and three men, aged between 46 and 72 years, with a diagnosis of spontaneous CSF fistula, four nasal and four otics who underwent surgical treatment. After repair, a diagnostic study was performed for IIH by MRI and angio-MRI, presenting in all cases a transverse venous sinus stenosis. The intracranial pressure values obtained by lumbar puncture showed values of 20mmHg or higher. All patients were diagnosed with IIH. The one-year follow-up did not reveal any recurrence of the fistulas, maintaining a control of the IIH. Conclusion: Despite their low frequency of both cranial CSF fistula and IIH, an association of both conditions should be considered by continuing the study and surveillance of these patients after fistula closure.(AU)

Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial.

Importance: Endotracheal tubes are typically inserted in the operating room using direct laryngoscopy. Video laryngoscopy has been reported to improve airway visualization; however, whether improved visualization reduces intubation attempts in surgical patients is unclear. Objective: To determine whether the number of intubation attempts per surgical procedure is lower when initial laryngoscopy is performed using video laryngoscopy or direct laryngoscopy. Design, Setting, and Participants: Cluster randomized multiple crossover clinical trial conducted at a single US academic hospital. Patients were adults aged 18 years or older having elective or emergent cardiac, thoracic, or vascular surgical procedures who required single-lumen endotracheal intubation for general anesthesia. Patients were enrolled from March 30, 2021, to December 31, 2022. Data analysis was based on intention to treat. Interventions: Two sets of 11 operating rooms were randomized on a 1-week basis to perform hyperangulated video laryngoscopy or direct laryngoscopy for the initial intubation attempt. Main Outcomes and Measures: The primary outcome was the number of operating room intubation attempts per surgical procedure. Secondary outcomes were intubation failure, defined as the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts, and a composite of airway and dental injuries. Results: Among 8429 surgical procedures in 7736 patients, the median patient age was 66 (IQR, 56-73) years, 35% (2950) were women, and 85% (7135) had elective surgical procedures. More than 1 intubation attempt was required in 77 of 4413 surgical procedures (1.7%) randomized to receive video laryngoscopy vs 306 of 4016 surgical procedures (7.6%) randomized to receive direct laryngoscopy, with an estimated proportional odds ratio for the number of intubation attempts of 0.20 (95% CI, 0.14-0.28; P < .001). Intubation failure occurred in 12 of 4413 surgical procedures (0.27%) using video laryngoscopy vs 161 of 4016 surgical procedures (4.0%) using direct laryngoscopy (relative risk, 0.06; 95% CI, 0.03-0.14; P < .001) with an unadjusted absolute risk difference of -3.7% (95% CI, -4.4% to -3.2%). Airway and dental injuries did not differ significantly between video laryngoscopy (41 injuries [0.93%]) vs direct laryngoscopy (42 injuries [1.1%]). Conclusion and Relevance: In this study among adults having surgical procedures who required single-lumen endotracheal intubation for general anesthesia, hyperangulated video laryngoscopy decreased the number of attempts needed to achieve endotracheal intubation compared with direct laryngoscopy at a single academic medical center in the US. Results suggest that video laryngoscopy may be a preferable approach for intubating patients undergoing surgical procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT04701762.

Impacto pronóstico a diez años del fallo del vaso diana tras un IAMCEST. Perspectivas del ensayo EXAMINATION-EXTEND / Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial

Introducción y objetivos Se desconoce el impacto pronóstico de los diferentes tipos de eventos adversos tras el infarto agudo de miocardio con elevación del segmento ST (IAMCEST). El objetivo de este trabajo es evaluar los predictores a largo plazo del objetivo combinado orientado al paciente (POCE) y si tener un fallo del vaso diana (FVD) como primer evento puede influir en los resultados. Métodos El ensayo EXAMINATION-EXTEND aleatorizó a pacientes con IAMCEST a tratamiento con stents liberadores de everolimus o a stents convencionales, con un seguimiento de hasta 10 años. En la población del estudio, se evaluaron los predictores de POCE (combinado de mortalidad por cualquier causa, infarto de miocardio y cualquier revascularización). Se clasificó a los pacientes según el tipo de primer evento (FVD primero o FDV no primero) y comparado en términos de POCE posterior. El FVD se definió como el compuesto de muerte cardiaca, IAMCEST del vaso diana y revascularización del vaso diana. Resultados De los 1.498 pacientes del estudio, 529 (35,3%) tuvieron POCE durante el seguimiento a los 10 años. Los predictores independientes de POCE fueron la edad, la diabetes mellitus, el infarto de miocardio previo, la enfermedad arterial periférica y la enfermedad coronaria multivaso. El primer evento fue un FVD o no FVD en 296 y 233 casos respectivamente. No hubo diferencias estadísticamente significativas entre quienes tuvieron primero un FVD y los que tuvieron un evento no FVD en cuanto a POCE (el 21,7 frente al 39,3%; razón de tiempo, 1,79; IC95%, 0,87-3,67; p=0,12) o sus componentes individuales. Conclusiones En el seguimiento a 10 años, alrededor de un tercio de los pacientes con IAMCEST tuvo al menos 1 evento de POCE, cuyos predictores independientes fueron la edad, la diabetes mellitus y una mayor extensión de la enfermedad ateroesclerótica... (AU)

Introduction and objectivesAfter ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. Methods The EXAMINATION.EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non–TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. Results Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non–TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67; P=.12) or its individual components. Conclusions At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. Trial registration number: NCT04462315. (AU)

New complementary alternatives in third molar autotransplantation: A systematic review

Background: Dental autotransplantation (DAT) is defined as the replacement or direct transfer of an impacted, semi-impacted or erupted tooth to a donor site, either to a post-extraction socket or to a surgically created socket within the same individual. The use of new technological advances, such as 3-D dental models based on computer-aided design, among others, have been reported to improve the success rate of DAT. Therefore, we aimed to perform a systematic review to explore the possible benefits that the use of these innovative techniques can provide when applied to DAT. Material and Methods: The literature search was conducted in PubMed, Scopus, and Web of Science databases following the PRISMA guidelines. The research question was: "Are computerized technological advancements a useful tool for improving the success of third molar autotransplantation technique? Results: The initial literature search identified 195 articles, of which only 11 were included for qualitative analysis. All studies used 3D dental models based on computer-aided design data. Surgical guides and stereolithographic models were used by 4 and 1 study respectively. A total of 91 transplanted teeth were evaluated, out of which only 88 were considered within the parameters of clinical success (96.7%). Only 7 out of the 11 articles reported the specific autotransplanted tooth, being mandibular third molars the most prevalent autotransplanted teeth. Conclusions: Although the application of new technologies for DAT increases the success rate of this technique, further primary studies are still needed to address long-term teeth survival rates and complications. The cost and availability to implement the integration of these techniques to DAT may be a variable to consider, as this can be a limitation for some patients or for low-income countries. (AU)

Proyecto DUCMA 2.0. Puesta al día sobre la situación actual de las unidades de Cirugía Mayor Ambulatoria en España / DUCMA 2.0 project: Update on the current situation of the outpatient surgery units in Spain

Introducción: La cirugía mayor ambulatoria (CMA) es un sistema de gestión seguro y eficiente para resolver los problemas quirúrgicos, pero su implantación y desarrollo ha sido variable. El objetivo de este estudio es describir las características, la estructura y el funcionamiento de las unidades de Cirugía Mayor Ambulatoria (UCMA) en España. Métodos: Estudio observacional, transversal, multicéntrico basado en una encuesta electrónica, con recogida de datos entre abril y septiembre de 2022. Resultados: En total, 90 UCMA completaron la encuesta. La media del índice de ambulatorización (IA) global es de 63%. Más de la mitad de las UCMA (52%) son de tipo integrado. La mitad las unidades imparte formación para médicos (51%) y personal de enfermería (55%). Los indicadores de calidad más utilizados son la tasa de suspensiones (87%) y de ingresos no previstos (80%). Conclusiones: Se necesita mayor coordinación entre administraciones para obtener datos fiables. Asimismo, se deben implementar sistemas de gestión de calidad en las unidades y desarrollar herramientas para la formación adecuada de los profesionales implicados.(AU)

Introduction: Ambulatory surgery is a safe and efficient management system to solve surgical problems, but its implementation and development has been variable. The aim of this study is to describe the characteristics, structure and functioning of ambulatory surgery units (ASU) in Spain. Methods: Multicenter, cross-sectional, observational study based on an electronic survey, with data collection between April and September 2022. Results: In total, 90 ASUs completed the survey. The mean overall ambulatory index is 63%. More than half of the ASUs (52%) are integrated units. Around half of the units provide training for physicians (51%) and for nurses (55%). The most frequently used quality indicators are suspension rate (87%) and the rate of unplanned admissions (80%). Conclusions: Greater coordination between administrations is needed to obtain reliable data. It is also necessary to implement quality management systems in the different units, as well as to develop tools for the adequate training of the professionals involved.(AU)