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INTRODUCTION: The European Association of Urology (EAU) and the American Society of Clinical Oncology (ASCO) recently issued updated guidelines on penile cancer, emphasising dynamic sentinel node biopsy (DSNB) as the preferred method for surgical staging among patients with invasive penile tumours and no palpable inguinal lymphadenopathy. This paper outlines the rationale behind this new recommendation and describes remaining challenges, as well as strategies for promoting DSNB worldwide. MAIN TEXT: DSNB offers high diagnostic accuracy with the lowest postoperative complications compared to open or minimally invasive inguinal lymph node dissection (ILND), prompting its preference in the new guidelines. Nevertheless, despite its advantages, there are challenges hampering the widespread adoption of DSNB. This includes the false-negative rate associated with DSNB and the potential negative impact on patient outcome. To address this issue, improvements should be made in several areas, including refining the timing and interpretation of the lymphoscintigraphy and the single photon emission computed tomography/computed tomography images. In addition, the quantity of tracer employed and choice of the injection site for the radiopharmaceutical should be optimised. Finally, limiting the removal of nodes without tracer activity during surgery may help minimise complication rates. CONCLUSION: Over the years, DSNB has evolved significantly, related to the dedicated efforts and innovations in nuclear medicine and subsequent clinical studies validating its efficacy. It is now strongly recommended for surgical staging among selected penile cancer patients. To optimise DSNB further, multidisciplinary collaborative research is required to improve SN identification for better diagnostic accuracy and fewer complications.
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Medicina Nuclear , Neoplasias Penianas , Guias de Prática Clínica como Assunto , Biópsia de Linfonodo Sentinela , Neoplasias Penianas/diagnóstico por imagem , Neoplasias Penianas/patologia , Humanos , Masculino , Biópsia de Linfonodo Sentinela/normas , Biópsia de Linfonodo Sentinela/métodos , Medicina Nuclear/normas , Europa (Continente)RESUMO
PURPOSE: Up to 90% of men with a positive surgical margin show remaining cancer in subsequent reresections. The risk of local recurrence in men with no penile cancer but the precancerous lesion penile intraepithelial neoplasia at the surgical margin is less well studied and was the aim of this analysis. MATERIAL AND METHODS: This was a retrospective analysis of men with distal penile cancer undergoing penile-sparing surgery. A competing risks survival analysis adjusted for grade, lymphovascular invasion, and stage was performed to assess local recurrence-free survival in patients with penile intraepithelial neoplasia-positive margins and completely negative surgical margins. RESULTS: A negative surgical margin was described in 319 men (85%), whereas penile intraepithelial neoplasia in the surgical margin was found in 59 men (15%). Local recurrence was observed in 30/319 men with a negative surgical margin compared to 11/59 men with penile intraepithelial neoplasia in the surgical margin. Adjusted for T stage and grade, patients with penile intraepithelial neoplasia at the surgical margin had a higher risk to develop a local recurrence than those with a negative surgical margin without penile intraepithelial neoplasia (HR 1.51, 95% CI 1.07-2.12, P = .019). CONCLUSIONS: Men with a penile intraepithelial neoplasia-positive surgical margin have an increased risk to experience local recurrence compared to men with a negative surgical margin and should undergo closer surveillance and/or adjuvant treatment.
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PURPOSE: To describe our surgical technique and report the oncological outcomes and complication rates using a fascial-sparing radical inguinal lymphadenectomy (RILND) technique for penile cancer patients with cN+ disease in the inguinal lymph nodes. METHODS: Over a 10-year period, 660 fascial-sparing RILND procedures were performed in 421 patients across two specialist penile cancer centres. The technique used a subinguinal incision with an ellipse of skin excised over any palpable nodes. Identification and preservation of the Scarpa's and Camper's fascia was the first step. All superficial inguinal nodes were removed en bloc under this fascial layer with preservation of the subcutaneous veins and fascia lata. The saphenous vein was spared where possible. Patient characteristics, oncologic outcomes and perioperative morbidity were retrospectively collected and analysed. Kaplan-Meier curves estimated the cancer-specific survival (CSS) functions after the procedure. RESULTS: Median (interquartile range, IQR) follow-up was 28 (14-90) months. A median (IQR) number of 8.0 (6.5-10.5) nodes were removed per groin. A total of 153 postoperative complications (36.1%) occurred, including 50 conservatively managed wound infections (11.9%), 21 cases of deep wound dehiscence (5.0%), 104 cases of lymphoedema (24.7%), 3 cases of deep vein thrombosis (0.7%), 1 case of pulmonary embolism (0.2%), and 1 case of postoperative sepsis (0.2%). The 3-year CSS was 86% (95%Confidence Interval [95% CI] 77-96), 83% (95% CI 72-92), 58% (95% CI 51-66), respectively, for the pN1, pN2 and pN3 patients (p < 0.001), compared to a 3-year CSS of 87% (95% CI 84-95) for the pN0 patients. CONCLUSION: Fascial-sparing RILND offers excellent oncological outcomes whilst decreasing the morbidity rates. Patients with more advanced nodal involvement had poorer survival rates, emphasizing the need for adjuvant chemo-radiotherapy.
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Neoplasias Penianas , Masculino , Humanos , Neoplasias Penianas/cirurgia , Neoplasias Penianas/patologia , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Excisão de Linfonodo/métodos , Veia Safena/patologia , Veia Safena/cirurgia , Fáscia , Canal Inguinal/patologia , Canal Inguinal/cirurgiaRESUMO
OBJECTIVES: To assess the accuracy of dynamic sentinel lymph node biopsy (DSNB) after negative ultrasonography (US) guided fine-needle aspiration (FNA) for inguinal lymph node (ILN) staging. PATIENTS AND METHODS: We performed a retrospective analysis of men with ≥T1G2 penile cancer and negative inguinal US-guided FNA undergoing DSNB. Men with suspicious US but negative FNA underwent US-guided ILN excision. Men with ≥T1G2 local recurrence during follow-up and non-squamous cell histologies were excluded. Descriptive analysis was performed, and sensitivity and negative predictive values (NPVs) were calculated. RESULTS: We included 403 men with 728 groins with negative FNA undergoing DSNB ± US-guided LN excision. At least one sentinel LN (SN) was visualised in 93% during the first and in 7% during the second lymphoscintigraphy. The median SNs visualised preoperatively was 1 SN and a median of 2 LNs were resected. ILN metastases were detected in 9% groins in men with impalpable and in 17% men with palpable LNs. Stratified by impalpable and palpable ILN, non-local recurrence despite pathologically negative DSNBs was seen in 0.5% and 0%, respectively. Limited to men with ≥24 months follow-up, non-local recurrence after negative DSNBs was seen in 0.4% and 0%, respectively. The sensitivity of DSNB was 96% and the NPV was 100%. The main limitation of this analysis is its retrospective nature with inherit biases. CONCLUSIONS: Inguinal US and FNA followed by DSNB can accurately stage men with both impalpable and palpable ILN, which provides logistical and surgical advantages.
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Neoplasias Penianas , Biópsia de Linfonodo Sentinela , Biópsia por Agulha Fina , Feminino , Virilha/patologia , Humanos , Linfonodos/patologia , Masculino , Estadiamento de Neoplasias , Neoplasias Penianas/patologia , Estudos Retrospectivos , UltrassonografiaRESUMO
OBJECTIVE: To develop a predictive model for additional inguinal lymph node metastases (LNM) at inguinal lymph node dissection (ILND) after positive dynamic sentinel node biopsy (DSNB) using DSNB characteristics to identify a patient group in which ILND might be omitted. PATIENTS AND METHODS: We conducted a retrospective study of 407 inguinal basins with a positive DSNB in penile cancer patients who underwent subsequent ILND from seven European centres. From the histopathology reports, the number of positive and negative lymph nodes, presence of extranodal extension and size of the metastasis were recorded. Using bootstrapped logistic regression, variables were selected for the clinical prediction model based on the optimization of Akaike's information criterion. The area under the curve (AUC) of the receiver-operating characteristic curve was calculated for the resulting model. Decision curve analysis (DCA) was used to evaluate the clinical utility of the model. RESULTS: Of the positive DSNBs, 64 (16%) harboured additional LNM at ILND. Number of positive nodes at positive DSNB (odds ratio [OR] 2.19, 95% confidence interval (CI) 1.17-4.00; P = 0.01) and largest metastasis size in mm (OR 1.06, 95% CI 1.03-1.10; P = 0.001) were selected for the clinical prediction model. The AUC was 0.67 (95% CI 0.60-0.74). The DCA showed no clinical benefit of using the clinical prediction model. CONCLUSION: A small but clinically important group of basins harbour additional LNM at completion ILND after positive DSNB. While DSNB characteristics were associated with additional LNM, they did not improve the selection of basins in which ILND could be omitted. Thus, completion ILND remains necessary in all basins with a positive DSNB.
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Neoplasias Penianas , Humanos , Excisão de Linfonodo , Linfonodos/patologia , Metástase Linfática/patologia , Masculino , Modelos Estatísticos , Estadiamento de Neoplasias , Neoplasias Penianas/patologia , Neoplasias Penianas/cirurgia , Prognóstico , Estudos Retrospectivos , Biópsia de Linfonodo Sentinela/métodosRESUMO
OBJECTIVES: To produce a best practice consensus guideline for the conduct of scrotal exploration for suspected testicular torsion using formal consensus methodology. MATERIALS AND METHODS: A panel of 16 expert urologists, representing adult, paediatric, general, and andrological urology used the RAND/UCLA Appropriateness Consensus Methodology to score a 184 statement pre-meeting questionnaire on the conduct of scrotal exploration for suspected testicular torsion. The collated responses were presented at a face-to-face online meeting and each item was rescored anonymously after a group discussion, facilitated by an independent chair with expertise in consensus methodology. Items were scored for agreement and consensus and the items scored with consensus were used to derive a set of best practice guidelines. RESULTS: Statements scored as with consensus increased from Round 1 (122/184, 66.3%) to Round 2 (149/200, 74.5%). Recommendations were generated in ten categories: consent, assessment under anaesthetic, initial incision, intraoperative decision making, fixation, medical photography, closure, operation note, logistics and follow-up after scrotal exploration. Our statements assume that the decision to operate has already been made. Key recommendations in the consent process included the discussion of the possibility of orchidectomy and the possibility of subsequent infection of the affected testis or wound requiring antibiotic therapy. If after the examination under anaesthesia, the index of suspicion of testicular torsion is lower than previously thought, then the surgeon should still proceed to scrotal exploration as planned. A flow chart guiding decision making dependent on intraoperative findings has been designed. If no torsion is present on exploration and the bell clapper deformity is absent, the testis should not be fixed. When fixing a testis using sutures, 3 or 4-point is acceptable and non-absorbable sutures are preferred. CONCLUSIONS: We have produced consensus recommendations to inform best practice in the conduct of scrotal exploration for suspected testicular torsion.
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BACKGROUND AND PURPOSE: Hemiscrotectomy with en bloc orchidectomy represents a radical primary, completion, or salvage option in men with inguinoscrotal cancers. We describe our surgical technique and peri-operative and oncological outcomes. PATIENTS AND METHODS: Retrospective cohort study of 16 men treated at a supra-regional referral centre with open radical hemiscrotectomy with or without en bloc orchidectomy between 2010 and 2020. Peri-operative and survival outcomes were analysed. RESULTS: Radical hemiscrotectomy with or without en bloc orchidectomy was performed on 16 patients comprising 7 well-differentiated liposarcomas, 4 dedifferentiated liposarcomas, 2 leiomyosarcomas, 1 mesothelioma, 1 rhabdomyosarcoma and 1 mammary type myofibroblastoma. Primary hemiscrotectomy was performed in four, completion hemiscrotectomy in nine and salvage hemiscrotectomy in three. The median hospital stay was 2 days [interquartile range (IQR) 2-4]. Four patients (25%) had post-operative complications including wound infection or haematoma. During a median follow-up of 18 months (IQR 2-66), one patient (6%) died following a recurrence in the pelvis and retroperitoneum. DISCUSSION: and Conclusions If careful dissection is performed, radical hemiscrotectomy and en bloc orchidectomy is a radical but safe procedure with a short hospital stay. Haematoma and infection represent the main complications, and within limited follow-up most men showed no recurrence.
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Recidiva Local de Neoplasia , Orquiectomia , Humanos , Masculino , Recidiva Local de Neoplasia/cirurgia , Encaminhamento e Consulta , Estudos Retrospectivos , Resultado do Tratamento , Reino UnidoRESUMO
OBJECTIVES: To identify predictive pathological factors for local recurrence (LR) and to study the impact of LR on survival in patients treated with glansectomy for penile squamous cell carcinoma (pSCC). PATIENTS AND METHODS: We retrospectively studied patients treated with glansectomy at international, high-volume reference centres. We analysed histopathological predictors of LR, stratified patients into risk groups based on the number of risk factors present, and studied the impact of LR on survival outcomes using Kaplan-Meier survival analysis and stepwise Cox proportional hazards regression models. Subsequently, we performed sensitivity analyses excluding margin-positive cases, pT3 disease, and cN+ disease, or all of these factors. RESULTS: Across nine institutions, 897 patients were included, of whom 94 experienced LR. On multivariable analysis, presence of high-grade disease and pT3 stage were independent predictors of LR. LR-free survival rates significantly differed according to the number of risk factors present, with a hazard ratio (HR) of 1.90 (95% confidence interval [CI] 1.17-3.07; P = 0.01) for the intermediate-risk group (one risk factor) and 6.11 (95% CI 3.47-10.77; P < 0.001) for the high-risk group (two risk factors), using the low-risk group (no risk factors) as reference. Patients who experienced LR had significantly worse overall survival (OS; HR 2.89, 95% CI 2.02-4.14; P < 0.001) and cancer-specific survival (CSS; HR 5.64, 95% CI 3.45-9.22; P < 0.001). LR (HR 3.82, 95% CI 2.14-6.8; P < 0.001), lymphovascular invasion and cN status were significant predictors of decreased CSS. LR remained a strong predictor of both OS and CSS in all sensitivity analyses. CONCLUSIONS: Pathological T3 stage and presence of high-grade disease were independent histopathological predictors of LR after glansectomy for primary pSCC, which allowed risk stratification into three groups with significantly different risk of developing LR. Additionally, LR is related to poor OS and CSS, indicating that LR is a manifestation of underlying aggressive disease and clearly challenging the dogma of using organ-sparing surgery whenever possible since survival is unaffected by higher LR rates.
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Carcinoma de Células Escamosas/secundário , Carcinoma de Células Escamosas/cirurgia , Recidiva Local de Neoplasia/patologia , Neoplasias Penianas/patologia , Neoplasias Penianas/cirurgia , Idoso , Humanos , Estimativa de Kaplan-Meier , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Invasividade Neoplásica , Estadiamento de Neoplasias , Tratamentos com Preservação do Órgão , Pênis/cirurgia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco , Taxa de SobrevidaRESUMO
BACKGROUND: Laser-based technologies have been commercially marketed as "wonder treatments" without a sufficient and adequate body of evidence. In addition, on July 30, 2018, the U.S. Food and Drug Administration issued a warning regarding the safety of the use of laser-based devices for the following indications: vaginal "rejuvenation" or cosmetic vaginal procedures, vaginal conditions and symptoms related to menopause, urinary incontinence, and sexual function. AIM: To perform a thorough review of the available literature regarding laser-based vaginal devices for the treatment of female genitourinary indications and summarize the results in several short statements according to the level of evidence. METHODS: A comprehensive review of the literature regarding laser treatments for gynecological indications was performed based on several databases. Eligible were studies that included at least 15 patients. OUTCOMES: Several aspects, including preclinical data, have been investigated. For each topic covered, data on laser-based devices were analyzed. RESULTS: Despite the high heterogeneity of studies and its limitations, the committee released several statements regarding the use of laser-based devices for genitourinary indications. CLINICAL IMPLICATIONS: Available data in the clinical setting are still poor, and the impact of these technologies on vaginal symptoms and signs has not been clearly established. STRENGTHS & LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. CONCLUSION: It is too early in the evolution and research of laser-based devices to make decisive recommendations regarding vaginal treatments. There is grave need to carry out randomized controlled trials with proper design for safety reasons, possible harm, and short-/long-term benefits for the different indications studied.
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Doenças Vaginais , Feminino , Humanos , Lasers , Menopausa , Comportamento SexualRESUMO
OBJECTIVES: To review the management and clinical outcomes of uni- or bilateral non-visualization of inguinal lymph nodes during dynamic sentinel lymph node biopsy (DSNB) in patients diagnosed with penile cancer and clinically impalpable inguinal lymph nodes (cN0), and to develop an algorithm for the management of patients in which non-visualization occurs. PATIENTS AND METHODS: This is a retrospective observational study over a period of 4 years, comprising 166 patients with penile squamous cell carcinoma undergoing DSNB and followed up for a minimum of 6 months. All cases diagnosed with uni- or bilateral non-visualization of sentinel nodes in this cohort were identified from a penile cancer database. The management of the inguinal lymph nodes after non-visualization and the oncological outcomes including local and regional recurrence rates were documented. RESULTS: Out of 166 consecutive patients undergoing DSNB, 20 patients (12%) had unilateral non-visualization after injection of intradermal 99m Tc. Of these 20 patients, seven underwent repeat DSNB at a later date, with six having successful visualization. One patient had persistent non-visualization and proceeded to a superficial modified inguinal lymphadenectomy (SML). None of these patients experienced recurrence at follow-up. A further seven patients underwent modified SML with on-table frozen-section analysis of the lymph node packet; none of these patients were found to have micrometastatic disease in the inguinal lymph nodes, although one patient developed metastatic inguinal node disease at a later date. Six patients elected to undergo clinical surveillance and have remained disease-free. CONCLUSION: Patients with impalpable inguinal lymph nodes undergoing DSNB with ≥G2 T1 disease should ideally have bilateral visualization of the sentinel lymph nodes, reflecting the drainage pattern from the primary tumour. In the present series, 12% of patients were found to have unilateral non-visualization after DSNB. Among patients offered a repeat DSNB at a later date, localizing the sentinel node was successful in 86% of cases. Patients with favourable histological characteristics can be placed on clinical surveillance. Those with high-risk disease can be offered a repeat DSNB procedure on the proviso that SML may be carried out if there is repeated non-visualization. Larger cohorts are required to validate this proposed algorithm.
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Algoritmos , Carcinoma de Células Escamosas/patologia , Canal Inguinal/diagnóstico por imagem , Metástase Linfática/diagnóstico por imagem , Neoplasias Penianas/patologia , Biópsia de Linfonodo Sentinela , Linfonodo Sentinela/patologia , Idoso , Carcinoma de Células Escamosas/diagnóstico por imagem , Carcinoma de Células Escamosas/terapia , Seguimentos , Humanos , Canal Inguinal/patologia , Masculino , Pessoa de Meia-Idade , Neoplasias Penianas/diagnóstico por imagem , Neoplasias Penianas/terapia , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Ultrassonografia de IntervençãoRESUMO
Male adult circumcision (MC) has been shown to reduce the risk of HIV transmission in men by 50-60 %. An upscaling in the training of providers to perform circumcision is necessary to meet demand since MC is a key component of essential surgery in the context of universal health coverage. We piloted a low-cost, high-fidelity model for training adult circumcision. Multi-centre, multinational data were collected on 74 trainees and clinicians (trainers) in sub-Saharan Africa. Both trainers and trainees gave excellent feedback for the model (content and face validity). The simulated model enables a safe and realistic simulation experience to perform MC. The model is quick to set up and easily transportable to multiple teaching sites.
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Circuncisão Masculina/educação , Treinamento por Simulação , Adulto , África Subsaariana , Humanos , Masculino , EnsinoRESUMO
INTRODUCTION: Surgical correction is advocated in patients with stable Peyronie's disease (PD) and severe curvature of the penis. Contemporary series demonstrate favorable outcomes based on relatively short follow-up periods. However, long-term follow-up is rarely reported and there is a paucity of evidence on the influence of patients' age, comorbidities, and natural history on surgical outcomes. AIMS: The present study aims to examine the influence of patient's age, comorbidities, severity of the disease, and natural history of PD on long-term outcomes and satisfaction following plaque incision and vein grafting for PD. METHODS: Patients with follow-up of more than 10 years who underwent plaque incision and grafting (Lue technique) for stable PD were included in the study. MAIN OUTCOME MEASURES: A combination of prospective and retrospective analysis of patients' histories, anatomical, functional, and surgical parameters, development of PD recurrences, improvements of sexual functions, and overall satisfaction were performed between 1992 and 2014. Multiple logistic regression models were applied to calculate adjusted odds ratios for predictors for development of erectile dysfunction (ED) and PD recurrence. RESULTS: Thirty patients with a median age of 57.5 years were eligible for inclusion in the study with a mean follow-up of 13.0 years (range 10.0-17.6). Angle of preoperative penile deviation was 40° to 110° (median 90°). On follow-up, 26 men (86.7%) had a straight erect penis. Eleven men (36.7%) developed ED, of whom 2 (6.7%) had other comorbidities contributing to their ED. Twenty-five men (83.3%) were still sexually active with or without medication. The mean percentage improvement in sexual function was 69.0%, with 17 men (56.7%) reporting 100% improvement and 7 (23.3%) reporting no improvement. Perceived penile shortening occurred in 13 patients (43.3%) and 6 patients (20.0%) experienced penile hyposensitivity. PD/plaque recurrence was found in 7 men (23.3%). The mean overall satisfaction with the procedure was 73.0%, with 18 men (60.0%) still 100% satisfied and 6 (20.0%) reporting satisfaction below 50%. CONCLUSION: Improvement of sexual function and overall satisfaction remain high at 10 years follow-up and make the technique a safe and effective form of treatment in carefully selected patients.
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Disfunção Erétil/cirurgia , Implante Peniano/métodos , Induração Peniana/cirurgia , Pênis/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Adulto , Idoso , Disfunção Erétil/fisiopatologia , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Induração Peniana/fisiopatologia , Prótese de Pênis , Estudos Prospectivos , Recidiva , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Penile cancer (PeCa) is a rare cancer with surgical options that affect patients' quality-of-life. Patient-reported outcome measures (PROMs) are uncommonly utilized in this cohort despite their several patient-centered benefits and there are recommendations to further digitalize PROMs. This prospective, population-based study aimed to report the development and feasibility of a novel electronic patient-reported outcome measures (ePROMs) questionnaire for patients with PeCa. MATERIALS AND METHODS: A novel ePROMs questionnaire was developed and sent to patients 3 days before outpatient clinic appointments. The questionnaire included up to 30 items on patient symptomology and quality-of-life, including a self-reported quality-of-life score (rated 0 being worst and 100 being best). Data were collected for patients followed up between August 2021 and May 2022. The primary feasibility outcomes, adherence and engagement, were measured by response and drop-out rates. Differences in responders and nonresponders were also ascertained. Secondary outcomes explored the clinical utility of the questionnaire. Responders were subcategorized into 3 groups: circumcision (Ci), partial penectomy (PP) or total penectomy (TP) and differences were analyzed. This study was approved by the local Trust Governance Panel, including for ethical considerations. RESULTS: 220 adult males were sent ePROMs questionnaires, and 141 (64%) responded initially. The mean dropout rate of subsequent questionnaires was 56%. The maximum number of questionnaires sent to and completed by a patient was 8 (n = 1). Nonresponders were older (P < .0001), with poorer performance status (P < .0001) and lower body mass index (P = .0288). TP patients reported the lowest median quality-of-life score 68.50 (8-99), followed by the Ci group (72.0, 37-94) and the PP group (76.0, 10-99). CONCLUSIONS: Patients initially engaged and adhered to the ePROMs questionnaire but struggled to maintain this over time. Clinical data gathered by the questionnaire may be utilized to inform patient care. The questionnaire requires additional validation, research, and education.
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BACKGROUND: Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients with impalpable disease. However, radical inguinal lymphadenectomy is associated with a high morbidity rate, and there is increasing usage of a videoendoscopic approach as an alternative. METHODS: A pragmatic, UK-wide multicentre feasibility randomised controlled trial (RCT), comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy. Patients will be identified and recruited from supraregional multi-disciplinary team meetings (sMDT) and must be aged 18 or over requiring inguinal lymphadenectomy, with no contraindications to surgical intervention for their cancer. Participants will be followed up for 6 months following randomisation. The primary outcome is the ability to recruit patients for randomisation across all selected sites and the rate of loss to follow-up. Other outcomes include acceptability of the trial and intervention to patients and healthcare professionals assessed by qualitative research and obtaining resource utilisation information for health economic analysis. DISCUSSION: There are currently no other published RCTs comparing videoendoscopic versus open radical inguinal lymphadenectomy. Ongoing study is required to determine whether randomising patients to either procedure is feasible and acceptable to patients. The results of this study may determine the design of a subsequent trial. TRIAL REGISTRATION: Clinicaltrials.gov PRS registry, registration number NCT05592639. Date of registration: 13th October 2022, retrospectively registered.
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CONTEXT: Lymph node (LN) involvement in penile cancer is associated with poor survival. Early diagnosis and management significantly impact survival, with multimodal treatment approaches often considered in advanced disease. OBJECTIVE: To assess the clinical effectiveness of treatment options available for the management of inguinal and pelvic lymphadenopathy in men with penile cancer. EVIDENCE ACQUISITION: EMBASE, MEDLINE, the Cochrane Database of Systematic Reviews, and other databases were searched from 1990 to July 2022. Randomised controlled trials (RCTs), nonrandomised comparative studies (NRCSs), and case series (CSs) were included. EVIDENCE SYNTHESIS: We identified 107 studies, involving 9582 patients from two RCTs, 28 NRCSs, and 77 CSs. The quality of evidence is considered poor. Surgery is the mainstay of LN disease management, with early inguinal LN dissection (ILND) associated with better outcomes. Videoendoscopic ILND may offer comparable survival outcomes to open ILND with lower wound-related morbidity. Ipsilateral pelvic LN dissection (PLND) in N2-3 cases improves overall survival in comparison to no pelvic surgery. Neoadjuvant chemotherapy in N2-3 disease showed a pathological complete response rate of 13% and an objective response rate of 51%. Adjuvant radiotherapy may benefit pN2-3 but not pN1 disease. Adjuvant chemoradiotherapy may provide a small survival benefit in N3 disease. Adjuvant radiotherapy and chemotherapy improve outcomes after PLND for pelvic LN metastases. CONCLUSIONS: Early LND improves survival in nodal disease in penile cancer. Multimodal treatments may provide additional benefit in pN2-3 cases; however, data are limited. Therefore, individualised management of patients with nodal disease should be discussed in a multidisciplinary team setting. PATIENT SUMMARY: Spread of penile cancer to the lymph nodes is best managed with surgery, which improves survival and has curative potential. Supplementary treatment, including the use of chemotherapy and/or radiotherapy, may further improve survival in advanced disease. Patients with penile cancer with lymph node involvement should be treated by a multidisciplinary team.
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Neoplasias Penianas , Humanos , Masculino , Excisão de Linfonodo , Linfonodos/patologia , Metástase Linfática/patologia , Estadiamento de Neoplasias , Neoplasias Penianas/patologiaRESUMO
OBJECTIVE: To demonstrate an ergonomic fourth arm technique to oversew the dorsal vascular complex (DVC) during robot-assisted laparoscopic prostatectomy (RALP). PATIENTS AND METHODS: Balloon of a Foley catheter inflated in the bulbar urethra. Fourth arm cranial traction via suture in the tip of the catheter. DVC oversewn under direct vision. RESULTS: Oversew of DVC with minimal patient-side surgical assistance. About a 50% reduction in apical positive margin rate. CONCLUSION: A useful, ergonomic method of oversewing the DVC during RALP.
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Laparoscopia/métodos , Prostatectomia/métodos , Robótica/métodos , Técnicas de Sutura , Falha de Equipamento , Ergonomia , Humanos , Laparoscopia/instrumentação , Masculino , Prostatectomia/instrumentação , Robótica/instrumentação , Suturas , Cateterismo UrinárioRESUMO
VELRAD is the first multicentre feasibility randomised controlled trial comparing videoendoscopic radical inguinal lymphadenectomy versus open dissection for male genital cancer. We have randomised nine patients so far in our attempt to identify the best approach to inguinal lymph node dissection.
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Neoplasias dos Genitais Masculinos , Neoplasias Penianas , Humanos , Masculino , Dissecação , Genitália Masculina , Excisão de Linfonodo , Neoplasias Penianas/cirurgia , Neoplasias Penianas/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Penile squamous cell carcinoma (PSCC) is characterised by stepwise lymphatic dissemination. Skip metastases (SkMs) are rare metastases in the corpus cavernosum or spongiosum without continuity to the primary tumour or its resection site. OBJECTIVE: To assess the distinct pattern of spread in SkM+ patients and the effect of SkM on prognosis. DESIGN, SETTING, AND PARTICIPANTS: We conducted a retrospective analysis of patients with SkM+ PSCC at ten high-volume international referral centres between January 2006 and May 2022. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We evaluated histopathological data, primary lymph node (LN) staging, and metastatic spread. We included a cohort of patients matched for pT stage, LN status, and grade who did not have SkM (SkM-) to compare the SkM prognosis and predictive value for cancer-specific mortality (CSM). RESULTS AND LIMITATIONS: Among the 63 SkM+ patients who met our inclusion criteria, the SkM diagnosis was synchronous in 54.0% and metastases were mostly located in the corpus cavernosum. SkM was symptomatic in 14% of cases, was detected on imaging in 32%, and was found incidentally on pathological examination in 27%. Fifty-one patients (81%) presented with positive LNs and 28 (44%) developed distant metastases. Seven patients (11%) presented with or developed distant metastasis without displaying any LN involvement. The 2-yr cancer-specific survival estimates were 36% (95% confidence interval [CI] 25-52%) for SkM+ and 66% (95% CI 55-80%) for matched SkM- patients (p < 0.001). On multivariable Cox regression analysis, SkM presence was an independent predictor for higher CSM (hazard ratio 2.05, 95% CI 1.06-4,12; p = 0.03). CONCLUSIONS: PSCC-related SkM is associated with aggressive disease behaviour and poor survival outcomes. Palpation of the entire penile shaft is essential, and distant staging is recommended in patients suspected of having SkM owing to the tendency for distant metastatic spread. PATIENT SUMMARY: We investigated outcomes for patients with cancer of the penis who had metastases in the tissues responsible for erection. We found that metastases in this location were associated with poor prognosis, even in the absence of more typical spread of cancer via the lymph nodes.
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CONTEXT: Penile cancer is a rare disease but has a significant impact on quality of life. Its incidence is increasing, so it is important to include new and relevant evidence in clinical practice guidelines. OBJECTIVE: To provide a collaborative guideline that offers worldwide physician and patient guidance for the management of penile cancer. EVIDENCE ACQUISITION: Comprehensive literature searches were performed for each section topic. In addition, three systematic reviews were conducted. Levels of evidence were assessed, and a strength rating for each recommendation was assigned according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology. EVIDENCE SYNTHESIS: Penile cancer is a rare disease but its global incidence is increasing. Human papillomavirus (HPV) is the main risk factor for penile cancer and pathology should include an assessment of HPV status. The main aim of primary tumour treatment is complete tumour eradication, which has to be balanced against optimal organ preservation without compromising oncological control. Early detection and treatment of lymph node (LN) metastasis is the main determinant of survival. Surgical LN staging with sentinel node biopsy is recommended for patients with a high-risk (≥pT1b) tumour with cN0 status. While (inguinal) LN dissection remains the standard for node-positive disease, multimodal treatment is needed in patients with advanced disease. Owing to a lack of controlled trials and large series, the levels of evidence and grades of recommendation are low in comparison to those for more common diseases. CONCLUSIONS: This collaborative penile cancer guideline provides updated information on the diagnosis and treatment of penile cancer for use in clinical practice. Organ-preserving surgery should be offered for treatment of the primary tumour when feasible. Adequate and timely LN management remains a challenge, especially in advanced disease stages. Referral to centres of expertise is recommended. PATIENT SUMMARY: Penile cancer is a rare disease that significantly impacts quality of life. While the disease can be cured in most cases without lymph node involvement, management of advanced disease remains challenging. Many unmet needs and unanswered questions remain, underlining the importance of research collaborations and centralisation of penile cancer services.
Assuntos
Infecções por Papillomavirus , Neoplasias Penianas , Urologia , Masculino , Humanos , Neoplasias Penianas/diagnóstico , Neoplasias Penianas/terapia , Neoplasias Penianas/patologia , Infecções por Papillomavirus/complicações , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/terapia , Qualidade de Vida , Doenças Raras , Estadiamento de Neoplasias , Excisão de Linfonodo/métodos , Metástase LinfáticaRESUMO
CONTEXT: There are several procedures for surgical nodal staging in clinically node-negative (cN0) penile carcinoma. OBJECTIVE: To evaluate the diagnostic accuracy, perioperative outcomes, and complications of minimally invasive surgical procedures for nodal staging in penile carcinoma. EVIDENCE ACQUISITION: A systematic review of the Medline, Embase, and Cochrane controlled trials databases and ClinicalTrials.gov was conducted. Published and ongoing studies reporting on the management of cN0 penile cancer were included without any design restriction. Outcomes included the false negative (FN) rate, the number of nodes removed, surgical time, and postoperative complications. EVIDENCE SYNTHESIS: Forty-one studies were eligible for inclusion. Four studies comparing robot-assisted (RA-VEIL) and video-endoscopic inguinal lymphadenectomy (VEIL) to open inguinal lymph node dissection (ILND) were suitable for meta-analysis. A descriptive synthesis was performed for single-arm studies on modified open ILND, dynamic sentinel node biopsy (DSNB) with and without preoperative inguinal ultrasound (US), and fine-needle aspiration cytology (FNAC). DSNB with US + FNAC had lower FN rates (3.5-22% vs 0-42.9%) and complication rates (Clavien Dindo grade I-II: 1.1-20% vs 2.9-11.9%; grade III-V: 0-6.8% vs 0-9.4%) in comparison to DSNB alone. Favourable results were observed for VEIL/RA-VEIL over open ILND in terms of major complications (2-10.6% vs 6.9-40.6%; odds ratio [OR] 0.18; p < 0.01). Overall, VEIL/RA-VEIL had lower wound-related complication rates (OR 0.14; p < 0.01), including wound infections (OR 0.229; p < 0.01) and skin necrosis (OR 0.16; p < 0.01). The incidence of lymphatic complications varied between 20.6% and 49%. CONCLUSIONS: Of all the surgical staging options, DSNB with inguinal US + FNAC had the lowest complication rates and high diagnostic accuracy, especially when performed in high-volume centres. If DSNB is not available, favourable results were also found for VEIL/RA-VEIL over open ILND. Lymphatic-related complications were comparable across open and video-endoscopic ILND. PATIENT SUMMARY: We reviewed studies on different surgical approaches for assessing lymph node involvement in cases with penile cancer. The results show that a technique called dynamic sentinel node biopsy with ultrasound guidance and fine-needle sampling has high diagnostic accuracy and low complication rates. For lymph node dissection in penile cancer cases, a minimally invasive approach may offer favourable postoperative outcomes.