A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD).

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.

Improved outcome in penile cancer with radiologically enhanced stratification protocol for lymph node staging procedures: a study in 316 inguinal basins with a mean follow-up of 5 years.

BACKGROUND: Lymph node metastasis is the main determinant of survival in penile cancer patients. Conventionally clinical palpability is used to stratify patients to Inguinal Lymph node dissection (ILND) if clinically node positive (cN +) or Dynamic sentinel node biopsy (DSNB) if clinically node negative (cN0). Studies suggest a false negative rate (FNR) of around 10% (5-13%) for DSNB. To our knowledge there are no studies reporting harder end point of survival and outcomes of all clinically node positive (cN +) patients. We present our outcome data of all patients with penile cancer including false negative rates and survival in both DSNB and ILND groups. METHODS: One hundred fifty-eight consecutive patients (316 inguinal basins), who had lymph node surgery for penile cancer in a tertiary referral centre from Jan 2008 to 2018, were included in the study. All patients underwent ultrasound (US) ± fine needle aspiration cytology (FNAC) and then MRI/ CT, if needed, to stage their disease. We used combined clinical and radiological criteria (node size, architecture loss, irregular margins) to stratify patients to DSNB vs ILND as opposed to clinical palpability alone. RESULTS: 11.2% i.e., 27/241 inguinal basins had lymph node positive disease by DSNB. 54.9% i.e., 39/71 inguinal basins (IBs) had lymph node-positive disease by ILND. 4 inguinal basins with no tracer uptake in sentinel node scans are being monitored at patient's request and have not had any recurrences to date. With a mean follow-up of 65 months (range 24-150), the false-negative rate (FNR) for DSNB is 0%. Judicious uses of cross-sectional imaging necessitated ILND in 2 inguinal basins with non-palpable nodes and negative US with false positive rate of 6.3% (2/32) for ILND. The same cohort of DSNB patients might have had 11.1% (3/27) FNR if only palpability criteria was used. 43 (28%) patients who did require cross sectional imaging as per our criteria had a low node positive rate of 4.7% (p = 0.03). Mean cancer specific survival of all node-positive patients was 105 months. CONCLUSION: The performance of DSNB improved with enhanced radiological stratification of patients to either DSNB or ILND. We for the first time report the comprehensive outcome of all lymph node staging procedures in penile cancer.

Videoendoscopic Inguinal Lymphadenectomy Versus Radical Open Dissection (VELRAD) in Patients with Male Genital Cancer: A Clinical Trial Update.

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.

Introducing minimally invasive inguinal lymph node dissection in a UK tertiary skin cancer service: Initial experience & outcomes.

AIMS: We report the first UK case series of minimally invasive inguinal lymphadenectomy (MILND) for patients with metastatic cutaneous pathology. METHODS: This was a retrospective, single-centre, single-surgeon cohort study. Twenty-one patients who underwent MILND from May 2015 to February 2019 were included. Demographic data, disease burden, and surgical quality assurance parameters were analysed. RESULTS: Median age was 69 (IQR: 58-76) with 14 women (66%) and 7 men (33%). Eighteen (85%) patients had melanoma with the rest having other skin malignancies. The median number of nodes resected was eight (IQR:6-11) and the median N-ratio was 0.18 [0.05-1.00]. The median surgical time for the procedure was 180 minutes (IQR: 147-225) Seven (33%) patients had complications--three trivial and four (19%) grade IIIB. Only one case (the first) was converted to an open procedure. CONCLUSIONS: We report the first UK series of MILND in a cutaneous oncology service. Our results show that MILND is a safe technique that can be introduced into a busy NHS practice with a structured training program, with surgical quality assurance outcomes identical to open inguinal lymphadenectomy. Our learning curve was similar to previously published data.

Use of Interrupted Time Series Analysis in Understanding the Course of the Congenital Syphilis Epidemic in Brazil.

Background: To fight against the rising incidence of syphilis, the Brazilian Ministry of Health (MoH) launched the "Syphilis No!" Project (SNP), with specific resources funded by a parliamentary amendment. Then, in 2018, a national rapid response started to be implemented on the Brazilian Unified Health System (SUS, Sistema Único de Saúde) in two strategic lines (1) to reinforce SUS's universal actions and (2) to implement specific ones to 100 municipalities chosen by the MoH as priorities for syphilis congenital response. In 2015, such localities represented 6895% of congenital syphilis cases in Brazil. In this context, SNP has implemented actions to strengthen epidemiological surveillance of acquired syphilis and congenital syphilis by instituting an integrated and collaborative response through health services networks and reinforcing interstate relations. Methods: A quasi-experimental study using time series analysis was conducted to assess immediate impacts and changes to the trend in national congenital syphilis before and after the project, from September 2016 to December 2019. Data were assessed considering rates of congenital syphilis per 1,000 live births in all priority municipalities (n=100) covered by the project and in non-priority municipalities (n=5,470) from all five macro-regions of Brazil. Findings: Priority municipalities showed a greater reduction (change in trend) in comparison to non-priority. The linear regression model revealed trend changes after the intervention, with both groups of municipalities showing a drop in the average monthly number of cases per 1,000 live births, with a reduction of -0·21 (CI 95% -0·33 to -0·09; p=0·0011) in priority municipalities and of -0·10 (CI 95% -0.19 to -0.02; p=0·0216) in non-priority municipalities. Interpretation: The study using ITS provides important evidence on the direction, timing, and magnitude of the effects of interventions introduced as part of the SNP on congenital syphilis in Brazil. Our results suggest that the Syphilis No! Project influenced the trends of congenital syphilis in Brazil from 2018, with higher reductions achieved in the priority municipalities. Funding: The research is funded by a grant to the Syphilis No! Project from Brazilian Ministry of Health (Project Number: 54/2017). The funders had no role in study design, analysis, decision to publish, or preparation of the manuscript.

Analyzing the reach of public health campaigns based on multidimensional aspects: the case of the syphilis epidemic in Brazil.

BACKGROUND: Public health campaigns aim to promote awareness, increase knowledge, and encourage a target population to adopt desirable attitudes and behaviors. Assessing their reach from a multidimensional perspective through information technology can facilitate the development of more effective campaigns in public health response. METHODS: We scrutinized seven data sources from different perspectives to assess a health campaign launched in Brazil named "Syphilis No!". This campaign is part of an Agenda for strategic actions to reduce syphilis in Brazil which includes dissemination of educommunication materials to remind people of the importance of syphilis prevention, emphasizing "test, treat and cure" concept. We developed a multidimensional analysis framework and implemented an information system to process the data from a time series perspective, and assessed the effects over time, both before and after the campaign. We descriptively analyzed data related to the campaign, including e-news, search engine activity, online courses, serological tests, medication distribution and case notification rates. FINDINGS: Regarding search engine activity, we observed the highest volume of search during the first week of campaigns in 2018 (between November 25th and December 7th). Nevertheless, analyzing this data in a trend plot revealed sustained growth until the end of 2019. From March 2018, the amount of e-news posts related to syphilis in Brazil, indexed by Google, followed an increasing slope, with a record peak in October 2019. In addition, data showed that 12 new online courses related to syphilis disease were available on the AVASUS Platform Learning Management System (LMS), to support efforts to promote lifelong learning for health professionals, teachers, and students. These courses reached more than 22,000 students between February 2019 and September 2020. Serological test data showed that the number of tests carried out in 2019 were 375·18% more than in 2015, even accounting for population growth. Finally, starting from the middle of 2018, the syphilis case notification rates followed a decreasing curve. INTERPRETATION: From this perspective, the "Syphilis No!" Project was a positive influence, inducing policy to fight syphilis in Brazil by supporting the implementation of a testing, treatment, and cure agenda (#TesteTrateCure). Certainly, this inference was made by analyzing multidimensional aspects and because, prior to 2018, the country had largely neglected this disease, with no records of communication actions during that period.

Management of penile cancer patients during the COVID-19 pandemic: An eUROGEN accelerated Delphi consensus study.

OBJECTIVES: To develop an international consensus on managing penile cancer patients during the COVID-19 acute waves. A major concern for patients with penile cancer during the coronavirus disease 2019 (COVID-19) pandemic is how the enforced safety measures will affect their disease management. Delays in diagnosis and treatment initiation may have an impact on the extent of the primary lesion as well as the cancer-specific survival because of the development and progression of inguinal lymph node metastases. MATERIALS AND METHODS: A review of the COVID-19 literature was conducted in conjunction with analysis of current international guidelines on the management of penile cancer. Results were presented to an international panel of experts on penile cancer and infection control by a virtual accelerated Delphi process using 4 survey rounds. Consensus opinion was defined as an agreement of ≥80%, which was used to reconfigure management pathways for penile cancer. RESULTS: Limited evidence is available for delaying penile cancer management. The consensus rate of agreement was 100% that penile cancer pathways should be reconfigured, and measures should be developed to prevent perioperative nosocomial transmission of COVID-19. The panel also reached a consensus on several statements aimed at reconfiguring the management of penile cancer patients during the COVID-19 pandemic. CONCLUSIONS: The international consensus panel proposed a framework for the diagnostic and invasive therapeutic procedures for penile cancer within a low-risk environment for COVID-19.

Systematic Review on Information Technology Approaches to Evaluate the Impact of Public Health Campaigns: Real Cases and Possible Directions.

Evaluating the success of a public health campaign is critical. It helps policy makers to improve prevention strategies and close existing gaps. For instance, Brazil's "Syphilis No!" campaign reached many people, but how do we analyze its real impact on population awareness? Are epidemiologic variables sufficient? This study examined literature on using of information technology approaches to analyze the impact of public health campaigns. We began the systematic review with 276 papers and narrowed it down to 17, which analyzed campaigns. In addition to epidemiological variables, other types of variables of interest included: level of (i) access to the campaign website, (ii) subject knowledge and awareness, based on questionnaires, (iii) target population's interest, measured from both online search engine and engagement with Social Network Service, and (iv) campaign exposure through advertising, using data from television commercials. Furthermore, we evaluated the impact by considering several dimensions such as: communication, epidemiology, and policy enforcement. Our findings provide researchers with an overview of various dimensions, and variables-of-interest, for measuring public campaign impact, and examples of how and which campaigns have used them.

Prospective study comparing video-endoscopic radical inguinal lymph node dissection (VEILND) with open radical ILND (OILND) for penile cancer over an 8-year period.

OBJECTIVE: To compare the complications and oncological outcomes between video-endoscopic inguinal lymph node dissection (VEILND) and open ILND (OILND) in men with carcinoma of the penis. PATIENTS AND METHODS: A prospectively collected institutional database was used to determine the outcomes in 42 consecutive patients undergoing ILND between 2008 and 2015 in a centre for treating penile cancer. Before 2013 all procedures were OILNDs. Since 2013 we have performed VEILND on all patients in need of ILND. The wound-related and non-wound-related complications, length of stay, and oncological safety between OILND and VEILND groups were compared. The mean duration of follow-up was 71 months for OILND and 16 months for the VEILND groups. RESULTS: In the study period 42 patients underwent 68 ILNDs (OILND 35, VEILND 33). The patients' demographics, primary stage and grade, and indications were comparable in both groups. There were no intraoperative complications in either group. The wound complication rate was significantly lower in the VEILND group at 6% compared to 68% in the OILND group. Lymphocoele rates were similar in both the groups (27% and 20%). The VEILND group had a better or the same lymph node yield, mean number of positive lymph nodes, and lymph node density confirming oncological safety. There were no groin recurrences in either group of patients. VEILND significantly reduced the mean length of stay by 4.8 days (P < 0.001). CONCLUSION: VEILND is an oncologically safe procedure with considerably low morbidity and reduced length of stay, at a mean (range) follow-up of 16 (4-35) months.

New ureteral stent design does not improve patient quality of life: a randomized, controlled trial.

PURPOSE: Ureteral stents result in significant morbidity in many patients. Manufacturers have altered stent design and composition to minimize symptoms. The Polaris™ stent is made of a Percuflex® combination, providing a firm proximal aspect with a softer distal aspect to minimize symptoms. In this prospective, randomized study we compared symptoms and quality of life after stent insertion to determine whether this stent is better tolerated than the InLay® stent. MATERIALS AND METHODS: Between September 2002 and September 2006 we randomized 159 patients requiring stent insertion for stone disease to receive the InLay or the Polaris ureteral stent. Patients were asked to complete the validated Ureteral Stent Symptom Questionnaire 2 weeks after stent insertion and 1 week after removal. RESULTS: A total of 98 patients completed and returned each questionnaire, including 45 with the InLay and 53 with the Polaris. There were no significant differences between the groups on any health domain assessed. In the InLay and Polaris groups 91% and 94% of patients experienced pain with the stent in situ, which decreased to 40% and 43%, respectively, after stent removal. The urinary symptom score with the stent in situ was equal in the 2 groups (32, maximum 55). Of the InLay and Polaris groups 60% and 66% of patients, respectively, would be against receiving a further stent due to symptoms (p = 0.79). CONCLUSIONS: The Polaris stent, designed with the specific aim of improving urinary symptoms and pain associated with ureteral stents, continues to have a significant detrimental effect on patient quality of life.

The use of capsaicin in loin pain-haematuria syndrome.

OBJECTIVE: To highlight the implications of the use of capsaicin in managing loin pain-haematuria syndrome (LPHS). PATIENTS AND METHODS: Between February 2002 and February 2007, three patients (one male and two females; mean age 31.7 years) with LPHS were managed with capsaicin and followed up for a period of 8-48 months. All were diagnosed with LPHS after negative urological investigations including urine culture, urine cytology, renal tract ultrasonography, intravenous urography and flexible cystoscopy; and nephrological work-ups including normal blood pressure measurements, creatinine clearance, urinary protein estimation and serum urea/creatinine. Five original papers were reviewed in detail for this article. Including our own experience, a total of 52 (including five bilateral) cases of LPHS treated with capsaicin are reviewed. RESULTS: Our patients received a total of four capsaicin instillations producing an average duration of pain relief per instillation of 17 weeks. There was evidence of renal deterioration in one, while another had worsened symptoms. The third patient continued his pain management within the pain clinic. The former two patients eventually underwent nephrectomy for poor function and extreme symptoms. CONCLUSION: Intrarenal capsaicin at best produces only short-term pain relief in more than half of patients with LPHS. It produces significant side-effects, i.e. UTI, bladder pain, and in up to half of patients, deteriorating symptoms. Further loss of functional renal tissue and a nephrectomy rate of 20-67% should be weighed against the benefits. We have therefore abandoned its use in treating LPHS or renal pain, and recommend that patients should be adequately counselled on its potential side-effects, including nephrotoxicity and increased nephrectomy rate.

Antegrade versus retrograde stenting in laparoscopic pyeloplasty.

PURPOSE: To compare operative times between retrograde and antegrade ureteral stenting as part of laparoscopic pyeloplasty. PATIENTS AND METHODS: Laparoscopic pyeloplasty procedures from January 2002 to January 2007 were identified through a prospective database. Procedures on 126 patients were performed using the same transperitoneal technique apart from the method of stent placement, which was performed in either a retrograde manner before laparoscopy or an antegrade manner during the laparoscopic portion of the procedure. RESULTS: A total of 45 patients underwent antegrade stenting, 53 had retrograde stenting, 20 patients already had a stent in place, and 8 patients had retrograde pyelography followed by antegrade stenting. Operative time in patients with antegrade stent placement was significantly faster than in those with retrograde stent placement (median 185 v 245 min, P < 0.0001 [two-way analysis of variance]), even when the variability of the operative surgeon was taken into account. There was no difference in the complication rates. CONCLUSION: Antegrade stent placement results in a significantly faster overall operative time when compared with retrograde stent placement.