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INTRODUCTION: Epithelioid angiosarcoma is a rare soft tissue sarcoma with a poor prognosis. We report two cases of patients who presented with a history of lower back pain, inflammatory signs and weight loss 5 and 6 years after endovascular aortic repair (EVAR) of an elective infrarenal abdominal aortic aneurysm (AAA). Imaging suggested graft infection but tissue samples revealed an epithelioid angiosarcoma. The objective is to report the clinical presentation, investigative modalities and immunohistochemical findings of an angiosarcoma after EVAR. PATIENTS AND METHODS: Two cases are described of an angiosarcoma of the aorta after EVAR. A literature search using PubMed, Embase and Web of Science was performed in English about angiosarcoma after EVAR published between 2007 and 2021. Relevant reports were selected and analysed. RESULTS: Fifteen case reports were identified, including the current two cases. Time to tumour detection after EVAR ranged from 6 to 120 months with a mean interval of 68 months. Most patients underwent endovascular repair of an AAA (13/15). Males (13 male/2 female patients) were predominant with a median age of 72 years (IQR 68-78 years). Over half of the patients had metastases at the time of diagnosis (9/15), most frequently in bones and liver. CONCLUSION: Diagnosis of angiosarcoma after EVAR remains challenging due to indistinctive clinical and radiological findings mimicking graft infection or endoleak. Angiosarcoma should be included in the differential diagnosis in patients previously treated with EVAR presenting with unintended weight loss, abdominal back pain and contrast enhancement of the aortic wall.AbbreviationsAAAabdominal aortic aneurysmCTAcomputed tomography angiographyCRPc-reactive proteinEVARendovascular aortic repairESRerythrocyte sedimentation rateFDGfluoro-deoxyglucoseMRImagnetic resonance imagingMeSHmedical subject headings.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Hemangiosarcoma , Humanos , Masculino , Femenino , Anciano , Reparación Endovascular de Aneurismas , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Resultado del Tratamiento , Hemangiosarcoma/diagnóstico , Hemangiosarcoma/etiología , Hemangiosarcoma/cirugía , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Factores de Tiempo , Complicaciones Posoperatorias/etiología , Endofuga/diagnóstico , Endofuga/etiología , Endofuga/cirugía , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVE: To determine whether proficiency-based progression (PBP) training leads to better robotic surgical performance compared to traditional training (TT), given that the value of PBP training for learning robotic surgical skills is unclear. MATERIALS AND METHODS: The PROVESA trial is a multicentric, prospective, randomized and blinded clinical study comparing PBP training with TT for robotic suturing and knot-tying anastomosis skills. A total of 36 robotic surgery-naïve junior residents were recruited from 16 training sites and 12 residency training programmes. Participants were randomly allocated to metric-based PBP training or the current standard of care TT, and compared at the end of training. The primary outcome was percentage of participants reaching the predefined proficiency benchmark. Secondary outcomes were the numbers of procedure steps and errors made. RESULTS: Of the group that received TT, 3/18 reached the proficiency benchmark versus 12/18 of the PBP group (i.e. the PBP group were ~10 times as likely to demonstrate proficiency [P = 0.006]). The PBP group demonstrated a 51% reduction in number of performance errors from baseline to the final assessment (18.3 vs 8.9). The TT group demonstrated a marginal improvement (15.94 vs 15.44) in errors made. CONCLUSIONS: The PROVESA trial is the first prospective randomized controlled trial on basic skills training in robotic surgery. Implementation of a PBP training methodology resulted in superior surgical performance for robotic suturing and knot-tying anastomosis performance. Compared to TT, better surgical quality could be obtained by implementing PBP training for basic skills in robotic surgery.
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Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Estudios Prospectivos , Anastomosis Quirúrgica , BenchmarkingRESUMEN
PURPOSE: We report the case of a venous iliocaval recanalization to preserve a transplant kidney. CASE REPORT: A young patient with a nephrotic syndrome caused by focal segmental glomerulosclerosis (FSGS) underwent a robot-assisted living-donor kidney transplant. The postoperative course was uneventful; serum creatinine at discharge was 1.51 mg/dL (normal range = 0.72-1.17 mg/dL). In the course of the following months, the patient was readmitted repeatedly due to acute kidney failure not related to rejection, recurrent FSGS, or anastomotic stenosis. All episodes started after prolonged standing and renal function improved after bed rest. Several hospital admissions and investigations later, phlebography revealed an occlusion of the inferior vena cava (IVC) and both common iliac veins with large collateral vessels through the azygos system. An endovenous recanalization of the iliocaval tract was performed, with subsequent normalization of transplant kidney function. CONCLUSION: Vascular complications after renal transplantation are an important cause of graft loss. We present an endovenous treatment option for a chronic occlusion of the IVC and common iliac vein with intermittent venous congestion as a cause of transplant failure.
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Glomeruloesclerosis Focal y Segmentaria , Trombosis de la Vena , Humanos , Glomeruloesclerosis Focal y Segmentaria/complicaciones , Grado de Desobstrucción Vascular , Trombosis de la Vena/etiología , Stents/efectos adversos , Resultado del Tratamiento , Vena Cava Inferior/diagnóstico por imagen , Vena Cava Inferior/cirugía , Riñón/fisiologíaRESUMEN
PURPOSE OF THE STUDY: To collect validity evidence for the chest tube insertion (CTI) test mode on the medical simulation application Touch Surgery. This was done by using Messick's contemporary framework. METHODS: Novice, intermediate and experienced participants provided informed consent and demographic information. After familiarisation with the application, they completed the CTI test mode. Validity evidence was collected from four sources: content, response process, relation to other variables and consequences. A post-study questionnaire with 5-point Likert scales assessed the perceived realism, relevance and utility of the assessment. Mean scores of the three groups were compared. RESULTS: A total of 25 novices, 11 intermediates and 19 experienced participants were recruited. Content evidence was collected by an expert in CTI and was based on published literature and guidelines. All users were familiarised with the application, and received standardised instructions throughout the test. Most users rated the simulation as realistic and suitable to assess cognitive skills. Novices received significantly lower (55.9±7.5) test mode scores than intermediates (80.6±4.4) (p<0.001) and experienced participants (82.3±5.3) (p<0.001). There was no significant difference in score between intermediate and experienced participants (p=0.75). Consequences evidence was provided by establishing a pass/fail score of 71% using the contrasting groups method, which resulted in one observed false positive and no false negatives. CONCLUSION: A robust validity argument was constructed for the CTI test mode, which can be implemented in surgical curricula to assess learners' cognitive skills prior to hands-on simulation practice.
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OBJECTIVE: To report the results of the robot-assisted kidney transplantation (RAKT) experience performed in 10 European centres by members of the European Robotic Urology Section (ERUS)-RAKT group. PATIENTS AND METHODS: This is a multicentre prospective observational study of RAKT. Descriptive analysis of recipients and donor characteristics, surgical data, intraoperative outcomes, complications rate and functional results were collected and analysed. RESULTS: Between July 2015 and September 2019, 291 living-donor RAKTs were performed. Recipients were mostly male (189 [65%]), the mean Standard deviation (sd) age was 45.2 (13.35) years, the mean (sd) body mass index was 27.13 (19.28) kg/m2 , and RAKT was pre-emptive in 155 (53.8%) cases. Right and multiple arteries kidneys were used in 15.4%. The mean (sd) total surgical and re-warming time was 244 (70.5) min and 53.16 (15.27) min, respectively. In all, 17 patients presented with postoperative bleeding (5.7%). Five kidneys had delayed graft function; five (2%) were lost due to thrombosis and one due to acute rejection. Two patients had arterial stenosis, three had incisional hernias, six had ureteric stenosis, and nine had lymphoceles. Neither surgical nor re-warming times were correlated with postoperative serum creatinine levels (P > 0.05). Comparison of surgical data between the first 120 cases and the following 171 cases showed a significantly shorter total surgical time in the second group (265 vs 230 min, P = 0.005). CONCLUSIONS: This is the largest European multicentre study of RAKT with good surgical and functional results competitive with open kidney transplant series, with a relatively short learning curve when performed in centres with a wide experience in open kidney transplantation and robotic surgery.
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Fallo Renal Crónico/cirugía , Trasplante de Riñón/métodos , Complicaciones Posoperatorias/epidemiología , Sistema de Registros , Procedimientos Quirúrgicos Robotizados/métodos , Sociedades Médicas , Urología , Europa (Continente)/epidemiología , Femenino , Humanos , Incidencia , Donadores Vivos/provisión & distribución , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Prospectivos , Tasa de Supervivencia/tendencias , Resultado del TratamientoRESUMEN
OBJECTIVES: To evaluate functional results, graft survival and late complications in patients who underwent robot-assisted kidney transplantation (RAKT) and who had a minimum of 1 year of follow-up data, and to analyse the correlations between surgical data and functional results at a minimum of 1-year postoperatively and between renal function in the immediate postoperative period and after 1 year. MATERIALS AND METHODS: A common prospectively collected RAKT database was created by the European Robotic Urological Section (ERUS) RAKT working group, which included eight different European centres. In each centre RAKTs were performed with kidneys from living donors. Data on demographic variables, surgical results, graft survival, functional outcomes (creatinine and estimated glomerular filtration rate [eGFR]) on postoperative days 7 and 30 and at 1 year, and late complications were extracted from the common database. RESULTS: A total of 147 RAKTs were performed by the ERUS RAKT working group. Of the 147 patients, 83 had at least 1-year follow-up (mean [range] 21 [13-27] months). Of these 83 patients, 30 were women. The patients' median (range) age was 43 (30-75) years, body mass index was 25.3 (20-40) kg/m2 , pre-transplantation serum creatinine was 517 (198-1 414) µmol/L and estimated GFR (eGFR) was 10 (3-29) mL/min per 1.73 m2 . Of the 83 cases, 46 were pre-emptive. The median (range) overall ischaemia time was 116 (53-377) min. The median (range) rewarming time was 60 (35-110) min. At 1-year follow-up, the median (range) serum creatinine was 131 (66-244) µmol/L, with a median (range) eGFR of 57.4 (28-97) mL/min per 1.73 m2 . There was no statistically significant difference between functional data at postoperative day 30 and those at 1 year for creatinine (P = 0.78) or eGFR (P = 0.91). Regarding the correlation between the surgical data and the functional outcomes, the data showed that overall operating time and rewarming time did not affect the graft function at 1 year. Three cases of graft loss occurred as a result of massive arterial thrombosis within the first postoperative week. Late complications comprised one case of ureteric stenosis and one case of graft pyelonephritis. No late vascular complications or cases of incisional hernia were recorded. CONCLUSION: Findings at 1-year follow-up indicate RAKT from a living donor to be a safe procedure in a properly selected group of recipients. RAKT was associated with a low complication rate and there was maintenance of excellent graft survival and function. This is the first and largest study to report functional results after RAKT from a living donor with a minimum follow-up of 1 year.
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Fallo Renal Crónico/cirugía , Trasplante de Riñón/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Adulto , Anciano , Creatinina/metabolismo , Europa (Continente) , Femenino , Tasa de Filtración Glomerular/fisiología , Supervivencia de Injerto/fisiología , Humanos , Fallo Renal Crónico/fisiopatología , Trasplante de Riñón/estadística & datos numéricos , Donadores Vivos , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Prospectivos , Recalentamiento , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Resultado del TratamientoRESUMEN
OBJECTIVE/BACKGROUND: This study aimed to determine the cost-effectiveness of a PROficiency based StePwise Endovascular Curricular Training (PROSPECT) program, including e-learning and hands on virtual reality simulation. METHODS: A prospective, single blinded, randomised controlled trial (RCT) was carried out to evaluate the impact of a PROSPECT training program on real life operative performance. Under supervision, all subjects performed two endovascular interventions on patients with symptomatic iliac and/or superficial femoral artery stenosis. Primary outcomes were technical performance (Global Rating Scale, Examiner Checklist), operative metrics, and patient outcomes, adjusted for case difficulty and the trainee's experience. Additionally, an analysis of costs and savings related to implementation of this endovascular training program was performed. Thirty-two general surgery trainees were randomised into three groups: group 1 (n = 11) received e-learning and simulation training (PROSPECT program); group 2 (n = 10) only had access to e-learning; group 3 (n = 11) did not receive supplementary education besides clinical training. Developmental cost, implementation cost, training time cost, and the operational cost of PROSPECT were determined. Time spent studying and practicing was converted to indirect saving of operating time. The costs of logistics, faculty time supervising simulation sessions, and 30 day complication rates were registered. Sensitivity analysis was performed to assess the robustness of the results. RESULTS: Fifty-eight peripheral endovascular interventions, performed by 29 surgical trainees (three dropouts) were included in this RCT from October 2014 to February 2016. Annual costs from the perspective of the hospital were 6589 for curriculum design, 31,484 for implementation, and 1143 in operational costs. Per trainee, simulation based training until proficiency cost 3806. In comparison, if endovascular proficiency levels were obtained with conventional training only, this may have cost 5001 per trainee. CONCLUSION: Simulation based training in endovascular procedures may be cost saving, because training occurs outside the angiosuite. It is possible that cost savings are underestimated as, in contrast to the literature, prevented costs related to complications could not be defined.
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Competencia Clínica , Simulación por Computador , Procedimientos Endovasculares/educación , Enseñanza , Instrucción por Computador , Curriculum , Humanos , Tempo Operativo , Estudios ProspectivosRESUMEN
OBJECTIVE: To assess the effect of patient-specific virtual reality rehearsal (PsR) before endovascular infrarenal aneurysm repair (EVAR) on technical performance and procedural errors. BACKGROUND: Endovascular procedures, including EVAR, are executed in a complex multidisciplinary environment, often treating high-risk patients. Consequently, this may lead to patient harm and procedural inefficiency. PsR enables the endovascular team to evaluate and practice the case in a virtual environment before treating the real patient. METHODS: A multicenter, prospective, randomized controlled trial recruited 100 patients with a nonruptured infrarenal aortic or iliac aneurysm between September 2012 and June 2014. Cases were randomized to preoperative PsR or standard care (no PsR). Primary outcome measures were errors during the real procedure and technical operative metrics (total endovascular and fluoroscopy time, contrast volume, number of angiograms, and radiation dose). RESULTS: There was a 26% [95% confidence interval (CI) 9%-40%, P = 0.004) reduction in minor errors, a 76% (95% CI 30%-92%, P = 0.009) reduction in major errors, and a 27% (95% CI 8.2%-42%, P = 0.007) reduction in errors causing procedural delay in the PsR group. The number of angiograms performed to visualize proximal and distal landing zones was 23% (95% CI 8%-36%, P = 0.005) and 21% (95% CI 7%-32%, P = 0.004) lower in the PsR group. CONCLUSIONS: PsR before EVAR can be used in different hospital settings by teams with various EVAR experience. It reduces perioperative errors and the number of angiograms required to deploy the stent graft, thereby reducing delays. Ultimately, it may improve patient safety and procedural efficiency.
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Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Endovasculares/efectos adversos , Aneurisma Ilíaco/cirugía , Complicaciones Intraoperatorias/prevención & control , Modelación Específica para el Paciente , Complicaciones Posoperatorias/prevención & control , Anciano , Anciano de 80 o más Años , Implantación de Prótesis Vascular/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Seguridad del Paciente , Práctica Psicológica , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Non-small cell lung cancer (NSCLC) is known for high relapse rates despite resection in early stages. Here, we present the results of a phase I clinical trial in which a dendritic cell (DC) vaccine targeting patient-individual neoantigens is evaluated in patients with resected NSCLC. Vaccine manufacturing is feasible in six of 10 enrolled patients. Toxicity is limited to grade 1-2 adverse events. Systemic T cell responses are observed in five out of six vaccinated patients, with T cell responses remaining detectable up to 19 months post vaccination. Single-cell analysis indicates that the responsive T cell population is polyclonal and exhibits the near-entire spectrum of T cell differentiation states, including a naive-like state, but excluding exhausted cell states. Three of six vaccinated patients experience disease recurrence during the follow-up period of 2 years. Collectively, these data support the feasibility, safety, and immunogenicity of this treatment in resected NSCLC.
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Antígenos de Neoplasias , Vacunas contra el Cáncer , Carcinoma de Pulmón de Células no Pequeñas , Diferenciación Celular , Células Dendríticas , Neoplasias Pulmonares , Linfocitos T , Vacunación , Humanos , Células Dendríticas/inmunología , Neoplasias Pulmonares/inmunología , Neoplasias Pulmonares/patología , Vacunas contra el Cáncer/inmunología , Carcinoma de Pulmón de Células no Pequeñas/inmunología , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Pulmón de Células no Pequeñas/terapia , Masculino , Femenino , Persona de Mediana Edad , Antígenos de Neoplasias/inmunología , Diferenciación Celular/inmunología , Anciano , Linfocitos T/inmunologíaRESUMEN
Objectives: Congenital tracheomalacia can be the cause of respiratory failure in young children. Although the indication for surgical treatment has already been discussed vigorously, no clear guidelines about the modality are available. Methods: Through a sternotomy approach, a combination of posterior pexy and anterior tracheopexy using a tailored ringed polytetrafluoroethylene prosthesis is performed. Patient demographic characteristics, as well as operative details and postoperative outcomes, are included in the analysis. Results: Between 2018 and 2022, 9 children underwent the operation under review. All patients showed severe clinical symptoms of tracheomalacia, which was confirmed on bronchoscopy. The median age was 9 months. There was no operative mortality. Eight patients could be weaned from the ventilator. One patient died because of interstitial lung disease with bronchomalacia and concomitant severe cardiac disease. The longest follow-up now is 4 years, and shows overall excellent clinical results, without any reintervention. Conclusions: Surgical treatment of tracheomalacia through a combination of posterior and anterior pexy is feasible, with acceptable short- and midterm results.
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INTRODUCTION: Assessments require sufficient validity evidence before their use. The Assessment for Competence in Chest Tube Insertion (ACTION) tool evaluates proficiency in chest tube insertion (CTI), combining a rating scale and an error checklist. The aim of this study was to collect validity evidence for the ACTION tool on a porcine rib model according to the Messick framework. METHODS: A rib model, consisting of a porcine hemithorax that was placed in a wooden frame, was used as simulator. Participants were recruited from the departments of surgery, pulmonology, and emergency medicine. After familiarization with the rib model and the equipment, standardized instructions and clinical context were provided. They performed 2 CTIs while being scored with the ACTION tool. All performances were assessed live by 1 rater and by 3 blinded raters using video recordings. Generalizability-analysis was performed and mean scores and errors of both groups on the first performance were compared. A pass/fail score was established using the contrasting groups' method. RESULTS: Nine novice and 8 experienced participants completed the study. Generalizability coefficients where high for the rating scale (0.92) and the error checklist (0.87). In the first CTI, novices scored lower than the experienced group (38.1/68 vs. 47.1/68, P = 0.042), but no difference was observed on the error checklist. A pass/fail score of 44/68 was established. CONCLUSION: A solid validity argument for the ACTION tool's rating scale on a porcine rib model is presented, allowing formative and summative assessment of procedural skills during training before patient contact.
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Objective: To compare binary metrics and Global Evaluative Assessment of Robotic Skills (GEARS) evaluations of training outcome assessments for reliability, sensitivity, and specificity. Background: GEARS-Likert-scale skills assessment are a widely accepted tool for robotic surgical training outcome evaluations. Proficiency-based progression (PBP) training is another methodology but uses binary performance metrics for evaluations. Methods: In a prospective, randomized, and blinded study, we compared conventional with PBP training for a robotic suturing, knot-tying anastomosis task. Thirty-six surgical residents from 16 Belgium residency programs were randomized. In the skills laboratory, the PBP group trained until they demonstrated a quantitatively defined proficiency benchmark. The conventional group were yoked to the same training time but without the proficiency requirement. The final trial was video recorded and assessed with binary metrics and GEARS by robotic surgeons blinded to individual, group, and residency program. Sensitivity and specificity of the two assessment methods were evaluated with area under the curve (AUC) and receiver operating characteristics (ROC) curves. Results: The PBP group made 42% fewer objectively assessed performance errors than the conventional group (P < 0.001) and scored 15% better on the GEARS assessment (P = 0.033). The mean interrater reliability for binary metrics and GEARS was 0.87 and 0.38, respectively. Binary total error metrics AUC was 97% and for GEARS 85%. With a sensitivity threshold of 0.8, false positives rates were 3% and 25% for, respectively, the binary and GEARS assessments. Conclusions: Binary metrics for scoring a robotic VUA task demonstrated better psychometric properties than the GEARS assessment.
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INTRO: Chest Tube Insertion (CTI) should be trained in simulated settings prior to patient contact. Feedback and certification is based on valid assessments, especially in simulation-based training. This study aimed to develop a novel assessment tool for CTI and to ensure content validity based on expert opinion collected through a structured Delphi study. METHODS: A diverse European expert panel was invited to participate. In round 1, the experts provided at least five procedural steps and three errors involved in CTI. Round 2 evaluated the level of agreement with the inclusion of each item in the assessment tool on a five-point Likert scale. In round 3, experts rated their agreement on inclusion of the procedural step with its descriptive anchors. Consensus was reached when ≥80% of participants agreed on an item's inclusion. RESULTS: Thirty-six of 105 (34%) invited surgeons (26/75, 35%), pulmonologists (8/23, 35%) and emergency physicians (2/7, 29%) participated. The overall response rate was 81% (29/36): 100% (36/36) in round 1, 83% (30/36) in round 2, and 97% (29/30) in round 3. Round 1 resulted in 23 steps and 44 errors after condensation and removal of duplicates. In round 2 consensus was achieved for 15 steps (65%) and 14 errors (32%). Nineteen steps were adapted into a rating scale with descriptive anchors and a list of 16 errors was presented to the panel. In round 3, experts reached consensus on the inclusion of 17 procedural steps (89%) with descriptive anchors and on all 16 errors. CONCLUSION: A multidisciplinary expert panel achieved consensus in the development of the ACTION (Assessment of Competence in Chest Tube Insertion) tool. This procedure-specific rating scale of 17 steps, supplemented with a checklist of 16 errors, requires further research to collect validity evidence.
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Tubos Torácicos , Cirujanos , Lista de Verificación , Competencia Clínica , Consenso , Técnica Delphi , HumanosRESUMEN
BACKGROUND: Kidney autotransplantation is a useful technique to be reserved for cases in which kidney function is compromised by a complex anatomical configuration, such as long ureteral strictures and renal vascular anomalies not suitable for in situ reconstruction. Robot-assisted kidney autotransplantation (RAKAT) presents a novel, minimally invasive, and highly accurate approach. OBJECTIVE: The aim of this study is to present the largest cohort of patients who underwent either extracorporeal (eRAKAT) or intracorporeal (iRAKAT) RAKAT, to confirm safety and feasibility and to compare the two approaches. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively analyzed prospectively followed patients undergoing eRAKAT and totally intracorporeal RAKAT in a total of three institutions. SURGICAL PROCEDURE: Extracorporeal RAKAT and iRAKAT. MEASUREMENTS: Surgical and functional outcomes of patients subjected to eRAKAT and iRAKAT were measured. RESULTS AND LIMITATIONS: Between January 2017 and February 2021, 29 patients underwent RAKAT: 15 eRAKAT and 14 iRAKAT. No statistical difference in the preoperative data was recorded. The analysis of intraoperative variables showed a statistically significant difference between eRAKAT and iRAKAT in cold ischemia time (median [interquartile range {IQR}]: 151 [125-199] vs 27.5 [20-55]; p < 0.001) and total ischemia time (median [IQR]: 196.2 [182-241] vs 81.5 [73-88]; p < 0.001). However, faster renal function recovery in favor of eRAKAT was observed during the first 90 d, with comparable renal function at 1 yr. The 90-d Clavien-Dindo >2 complications were 13.8%. It is important to stress that RAKAT, and above all iRAKAT, should be performed by surgeons with experience in robotic renal, vascular, and transplant surgery. CONCLUSIONS: Both eRAKAT and iRAKAT represent promising minimally invasive techniques in selected cases with acceptable ischemia time and comparable long-term operative outcomes. PATIENT SUMMARY: In selected patients, both extra- and intracorporeal robot-assisted kidney autotransplantation represent valid alternatives in case of long ureteral strictures and renal vascular anomalies not suitable for in situ reconstruction.
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Procedimientos Quirúrgicos Robotizados , Robótica , Obstrucción Ureteral , Constricción Patológica/etiología , Femenino , Humanos , Isquemia/complicaciones , Isquemia/cirugía , Riñón/cirugía , Masculino , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Trasplante Autólogo , Resultado del Tratamiento , Obstrucción Ureteral/etiología , Obstrucción Ureteral/cirugíaRESUMEN
Consensus on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) is lacking, and comparison between studies remains difficult due to a large variety in outcome measures. We aimed to define a core outcome set (COS) for pediatric patients with an asymptomatic CPAM. An online, three-round Delphi survey was conducted in two stakeholder groups of specialized caregivers (surgeons and non-surgeons) in various European centers. Proposed outcome parameters were scored according to level of importance, and the final COS was established through consensus. A total of 55 participants (33 surgeons, 22 non-surgeons) from 28 centers in 13 European countries completed the three rounds and rated 43 outcome parameters. The final COS comprises seven outcome parameters: respiratory insufficiency, surgical complications, mass effect/mediastinal shift (at three time-points) and multifocal disease (at two time-points). The seven outcome parameters included in the final COS reflect the diversity in priorities among this large group of European participants. However, we recommend the incorporation of these outcome parameters in the design of future studies, as they describe measurable and validated outcomes as well as the accepted age at measurement.
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Kidney transplantation is universally recognized as the gold standard treatment in patients with End-stage Kidney Disease (ESKD, or according to the latest nomenclature, CKD stage 5). Robot-assisted kidney transplantation (RAKT) is gradually becoming preferred technique in adults, even if applied in very few centra, with potentially improved clinical outcomes compared with open kidney transplantation. To date, only very few RAKT procedures in children have been described. Kidney transplant recipient patients, being immunocompromised, might be at increased risk for perioperative surgical complications, which creates additional challenges in management. Applying techniques of minimally invasive surgery may contribute to the improvement of clinical outcomes for the pediatric transplant patients population and help mitigate the morbidity of KT. However, many challenges remain ahead. Minimally invasive surgery has been consistently shown to produce improved clinical outcomes as compared to open surgery equivalents. Robot-assisted laparoscopic surgery (RALS) has been able to overcome many restrictions of classical laparoscopy, particularly in complex and demanding surgical procedures. Despite the presence of these improvements, many challenges lie ahead in the surgical and technical-material realms, in addition to anesthetic and economic considerations. RALS in children poses additional challenges to both the surgical and anesthesiology team, due to specific characteristics such as a small abdominal cavity and a reduced circulating blood volume. Cost-effectiveness, esthetic and functional wound outcomes, minimal age and weight to undergo RALS and effect of RAKT on graft function are discussed. Although data on RAKT in children is scarce, it is a safe and feasible procedure and results in excellent graft function. It should only be performed by a RAKT team experienced in both RALS and transplantation surgery, fully supported by a pediatric nephrology and anesthesiology team. Further research is necessary to better determine the value of the robotic approach as compared to the laparoscopic and open approach. Cost-effectiveness will remain an important subject of debate and is in need of further evaluation as well.
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INTRODUCTION: A worldwide lack of consensus exists on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) even though the incidence is increasing. Either a surgical resection is performed or a wait-and-see policy is employed, depending on the treating physician. Management is largely based on expert opinion and scientific evidence is scarce. Wide variations in outcome measures are seen between studies making comparison difficult thus highlighting the lack of universal consensus in outcome measures as well. We aim to define a core outcome set which will include the most important core outcome parameters for paediatric patients with an asymptomatic CPAM. METHODS AND ANALYSIS: This study will include a critical appraisal of the current literature followed by a three-stage Delphi process with two stakeholder groups. One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists. All participants will score outcome parameters according to their level of importance and the most important parameters will be determined by consensus. ETHICS AND DISSEMINATION: Electronic informed consent will be obtained from all participants. Ethical approval is not required. After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.
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Evaluación de Resultado en la Atención de Salud , Investigadores , Niño , Consenso , Técnica Delphi , Humanos , Recién Nacido , Proyectos de Investigación , Encuestas y CuestionariosRESUMEN
Introduction and Objectives: Kidney autotransplantation can be performed in patients with complex renal or ureteral pathology not suitable for in situ reconstruction, such as renal vasculature anomalies, patients with proximal or long complex ureteral strictures, or complex oncological cases. Robot-assisted surgery allows for a high-quality vascular and ureteral anastomosis and faster patient recovery. Robot-assisted kidney autotransplantation (RAKAT) is performed in two phases: nephrectomy and pelvic transplantation. In-between, extraction of the kidney allows for vascular reconstruction or kidney modification on the bench and safe cold ischemia can be established. If no bench reconstruction is needed, total intracorporeal RAKAT (tiRAKAT) is feasible. One case report in Europe has been described; however, to our knowledge no surgical video is available. Methods: A 58 year-old woman suffered from right mid- and distal ureteral stenosis following pelvic radiotherapy 10 years prior for cervical cancer. A JJ stent was placed, but she suffered from recurrent urinary tract infections, and ultimately a nephrostomy was placed. Renogram demonstrated 43% relative right kidney function. As her bladder volume was low following radiotherapy, no Boari flap was possible and the patient refused life-long nephrostomy or nephrectomy. Therefore, tiRAKAT was performed using the DaVinci Xi system. Results: We describe our surgical technique including a video. Surgical time (skin-to-skin) was 5 h and 45 min. Warm ischemia time was 4 min, cold ischemia 55 min, and rewarming ischemia 15 min. The abdominal catheter and bladder catheter were removed on the first and second postoperative day, respectively. The JJ stent was removed after 4 weeks. The patient suffered from pulmonary embolism on the second postoperative day, for which therapeutic low molecular weight heparin was started. No further complications occurred during the first 90 postoperative days. After 7 months, overall kidney function remained stable, right kidney function dropped non-significantly from 27 to 25.2 mL/min (-6.7%) on renal scintigraphy. Conclusion: We demonstrated feasibility and, for the first time, a surgical video of tiRAKAT highlighting patient positioning, trocar placement, and intracorporeal cold ischemia technique.
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PURPOSE: Robotic endovascular technology may offer advantages over conventional manual catheter techniques. Our aim was to compare the endovascular catheter path-length (PL) for robotic versus manual contralateral gate cannulation during endovascular aneurysm repair (EVAR), using video motion analysis (VMA). METHODS: This was a multicentre retrospective cohort study with fluoroscopic video recordings of 24 EVAR cases (14 robotic, 10 manual) performed by experienced operators (> 50 procedures), obtained from four leading European centres. Groups were comparable with no statistically significant differences in aneurysm size (p = 0.47) or vessel tortuosity (p = 0.68). Two trained assessors used VMA to calculate the catheter PL during contralateral gate cannulation for robotic versus manual approaches. RESULTS: There was a high degree of inter-observer reliability (Cronbach's α > 0.99) for VMA. Median robotic PL was 35.7 cm [interquartile range, IQR (30.8-51.0)] versus 74.1 cm [IQR (44.3-170.4)] for manual cannulation, p = 0.019. Robotic cases had a median cannulation time of 5.33 min [IQR (4.58-6.49)] versus 1.24 min [IQR (1.13-1.35)] in manual cases (p = 0.0083). Generated efficiency ratios (PL/aorto-iliac centrelines) was 1.6 (1.2-2.1) in robotic cases versus 2.6 (1.7-7.0) in manual, p = 0.031. CONCLUSION: Robot-assisted contralateral gate cannulation in EVAR leads to decreased navigation path lengths and increased economy of movement compared with manual catheter techniques. The benefit could be maximised by prioritising robotic catheter shaping over habituated reliance on guidewire manipulation. Robotic technology has the potential to reduce the endovascular footprint during manipulations even for experienced operators with the added advantage of zero radiation exposure.
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Aneurisma/cirugía , Cateterismo/métodos , Procedimientos Endovasculares/métodos , Procedimientos Quirúrgicos Robotizados , Diseño de Equipo , Femenino , Fluoroscopía , Humanos , Masculino , Reproducibilidad de los Resultados , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Kidney autotransplantation (KAT) is the ultimate way to salvage kidneys with complex renovascular, ureteral, or malignant pathologies that are not amenable to in situ reconstruction. A minimally invasive approach could broaden its adoption. OBJECTIVE: To describe operative technique, perioperative complications, and early functional outcomes of robot-assisted kidney autotransplantation (RAKAT). DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of prospectively collected data regarding consecutive patients undergoing RAKAT between March 2017 and February 2018 at two university hospitals. INTERVENTION: RAKAT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Technical feasibility, perioperative complications, and early functional results. RESULTS AND LIMITATIONS: Seven patients underwent RAKAT (three male and four female; five left and two right; one totally intracorporeal) for complex ureteral strictures (n=5), severe left renal vein nutcracker (n=1), and loin pain hematuria syndrome (n=1). Two patients underwent bench vascular reconstruction and one patient underwent ex vivo flexible ureterorenoscopy. No patient needed open conversion. Median operative and console time was 370 and 255min, respectively, with median vascular and ureteral anastomosis time of 28 and 23min, respectively. Median warm, cold, and rewarming ischemia time was 2, 178, and 44min, respectively. One major postoperative complication occurred-wound dehiscence needing wound revision (grade 3b). Median hospital stay was 5 d. At 3 mo, all patients were free of indwelling stents, pain, or hematuria. Median serum creatinine at 3 mo was 0.80mg/dl and median calculated autotransplant glomerular filtration rate did not drop significantly. CONCLUSIONS: RAKAT is feasible, safe, and results in good functioning of the autotransplant in selected patients with complex ureteral strictures, loin pain hematuria, or severe nutcracker syndrome. Larger studies with longer follow-up are needed to confirm these findings and to test whether RAKAT is feasible for other KAT indications. PATIENT SUMMARY: We describe the first series worldwide of a minimally invasive technique for kidney autotransplantation. Robot-assisted kidney autotransplantation is a safe and feasible approach to prevent nephrectomy for intractable symptoms in selected patients with complex ureteral or renal pathology.