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.

Primary squamous cell carcinoma of the scrotum: Outcomes from a specialist center.

BACKGROUND: Squamous cell carcinoma (SCC) of the scrotum is a rare and aggressive cancer. There are no established guidelines on the management of scrotal SCC. OBJECTIVE: To analyze the clinical management and outcomes of scrotal SCC. PATIENTS AND METHODS: A retrospective analysis of patients diagnosed with primary scrotal SCC over a 10-year period was performed. The type of surgery, tumor stage and histological subtypes, recurrence rate and metastases, cancer-specific mortality (CSM), and other-cause mortality (OCM) were analyzed. RESULTS: Between 2012 and 2022, a total of 10 men were identified with primary scrotal SCC. The median (interquartile, IQR) age was 65.5 (55-77) years. Wide local excision was performed in 9 patients and 1 patient underwent a total scrotectomy. The pathological T-stage was: pT1, n = 3; pT2, n = 1; pT3, n = 5 (50%); pT4, n = 1. Four patients had pathologically positive inguinal lymph nodes and 2 had distant metastatic disease at presentation. At a median (IQR) follow-up of 10.5 (4-31) months 5 patients died, of which 3 died from scrotal SCC. CONCLUSION: Scrotal SCC is extremely rare in the UK with only 10 primary cases identified in our center over the past 10 years. Surgical resection of the tumor and appropriate inguinal node staging are required due to a high proportion of cases which metastasize to the inguinal lymph nodes. PATIENT SUMMARY: Scrotal cancer is rare. 10 cases were diagnosed over 10 years at a single center. Around half had disease spread to the groin nodes or distant organs at presentation. Surgical resection was required in all patients. At the time of analysis, half of the patients are alive. Due to the rarity and aggressiveness of the cancer, management should be carried out within a specialist center.

Complications and outcomes following injection of foreign material into the male external genitalia for augmentation: a single-centre experience and systematic review.

Injection of exogenous material into the penis and scrotum has been performed for augmentation purposes. Complications include cosmetic dissatisfaction, penile necrosis and lymphoedema. We report the complications and outcomes from a single centre with an updated systematic review of the literature. A retrospective review of all cases presenting with foreign substance injection into the genitalia, over a 10-year period was performed. Thirty-five patients with a mean (standard deviation (SD); range) age of 36.9 (±9.1; 22-61) years at presentation were included. The mean (SD; range) time between injection and presentation was 7.8 (±5.8; 1 day-20 years) years. The most common injected substance was silicone (n = 16, 45.7%) and liquid paraffin (n = 8, 22.9%). The penile shaft (94.3%) was the most injected site. The most common presentations were cosmetic dissatisfaction (57.1%) and pain and/or swelling (45.7%). Surgery was required in 32 (91.4%) cases. Primary procedures included local excision and primary closure (n = 19, 59.4%), circumcision (n = 5, 15.6%), excision with a split skin graft or a scrotal flap reconstruction (n = 5, 15.6%). Three (8.6%) patients presented with necrosis and required acute debridement. Overall, 18 patients had more than 1 procedure, and 8 patients required 3 or more procedures. A systematic search of the literature identified 887 articles of which 68 studies were included for analysis. The most common substance injected was paraffin (47.7%), followed by silicone (15.8%). The majority of patients (77.9%) presented with pain, swelling or penile deformity. 78.8% of the patients underwent surgical treatment, which included excision and primary closure with or without the use of skin grafts (85.1% of all procedures), the use of flaps (12.3%) and penile amputation (n = 2). Complications of foreign body injection into the male genitalia can be serious resulting in necrosis and autoamputation. Surgical intervention is often required to excise abnormal tissue to manage pain and improve cosmesis.

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.

Treatment of Persistent or Recurrent Varicoceles: A Systematic Review.

CONTEXT: The outcomes and morbidity following treatment for persistent or varicocele recurrence remain controversial. OBJECTIVE: To conduct a systematic review relating to the outcomes following treatment (any surgical or radiological) for varicocele persistence/recurrence. EVIDENCE ACQUISITION: A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Prospective and retrospective observational or interventional studies were included until March 2022. Outcomes were pregnancy rate, improvements in semen parameters after treatment compared with those at baseline, pain control, complication rates, and repeat treatment approach. Men of any age with any-grade persistent/recurrent varicoceles were included. EVIDENCE SYNTHESIS: Of 913 articles identified, 18 with 1073 patients were eligible for inclusion. The mean time between the first and repeat treatment ranged between 5.3 and 73.3 months. The indication for repeat treatment was infertility in eight and pain control in six out of 18 studies, whereas four did not provide details for the indication. Of the patients with recurrent/persistent varicoceles initially treated using a radiological intervention, 83.8% underwent another radiological procedure, whereas 16.2% underwent a surgical procedure. Of those initially treated with a surgical procedure, 77.8% underwent a further surgical procedure, whereas 22.2% underwent a radiological procedure. The rate of success of repeat treatment was 60-100%. The reported complications were as follows: hydrocele (up to 16%), testicular atrophy (up to 2%), scrotal hematoma (up to 1.6%), wound infection (up to 6.6%), chronic pain (up to 2.9%), injury to other organs (up to 10%), and thrombophlebitis (up to 5.8%). The rate of symptom resolution was >90% for pain control. Pregnancy rates were 17-58% at 12-month follow-up. Semen parameters improved after repeat treatment compared with that at baseline in 87.5% of studies. The main limitations are the high risk of bias according to the Newcastle and Ottawa Scale, heterogeneity of the included studies, and small simple size. CONCLUSIONS: Treating any grade of persistent/recurrent varicoceles has a good rate of success, pregnancy, and pain control, but there is still a risk of complications. Repeat treatment with the same interventional modality is feasible. The level of evidence is overall low. PATIENT SUMMARY: In this systematic review on persistent or recurrent varicoceles, we showed that repeat treatment with radiological or surgical procedures was feasible, with good success, pregnancy, and pain control rates at follow-up. However, repeat treatment was associated with a higher risk of complications than reported in the published literature relating to patients having their first intervention.

Chest computed tomography for staging renal tumours: validation and simplification of a risk prediction model from a large contemporary retrospective cohort.

OBJECTIVES: To externally validate a nomogram recently proposed by Larcher et al. (BJU Int. 2017; 120: 490) and to develop a simplified model with comparable accuracy to guide on the need for staging chest computed tomography (CT) for patients with new renal masses. PATIENTS AND METHODS: We analysed the data of 1082 consecutive patients with unilateral enhancing renal masses referred to urology multidisciplinary team meetings at two centres between 2011 and 2017. All patients underwent a staging chest CT at diagnosis. We fitted multivariable logistic regression models and tested the Larcher model performance using area under the receiver-operating curve (AUC), calibration and decision curve analysis. RESULTS: Forty-two patients (3.9%) had a positive chest CT. The Larcher nomogram had an AUC of 83.8% (95% confidence interval [CI] 77.1-90.6), but was only moderately well calibrated (calibration-in-the-large = -0.61, slope = 0.82). Specifically, the nomogram overestimated the risk of positive chest CT, and the magnitude of miscalibration increased with increasing predicted risks. Using a stepwise backward approach, a new model was developed including tumour size, nodal stage and systemic symptoms. Compared with the Larcher model, the new model had a similar AUC (82.7% [95% CI 75.5-90.0]), but improved calibration and clinical net benefit. The predicted risk of positive chest CT was <1% in the low-risk group and 1.9-79.9% in the high-risk group. CONCLUSION: The Larcher nomogram is an accurate prediction tool that was moderately well calibrated with our dataset. However, our simplified model has similar accuracy and uses more objective variables available from referral, so may be easier to incorporate into clinical practice. The low-risk group from our model (tumour size ≤4 cm and no systemic symptoms) had a risk of positive chest CT <1%, suggesting these patients may forego chest CT.

See the Seal? Understanding Restrained Eaters' Responses to Nutritional Messages on Food Packaging.

Food packaging in general and packaging incorporating health messages in particular have been active areas of inquiry, receiving attention from policymakers and food manufacturers alike. This study explores the effects of package seals and claims on perceived product healthfulness as a function of dietary restraint status. A laboratory experiment using realistic three-dimensional packaging shows that for restrained eaters (i.e., those who try to restrict their food intake), nutrition claims on "healthy" products and nutrition seals on "unhealthy" products are effective at enhancing perceptions of product healthfulness. Unrestrained eaters, in contrast, are largely unaffected by nutrition seals and claims. These results provide insights into restrained eaters' purchase motivations, as well as guidance for policymakers seeking to regulate the use of seals and claims.