Inguinal Lymphadenectomy for Penile Cancer: an Interim Report From a Prospective Randomized Clinical Trial Comparing Open vs. Video-endoscopic Approach

Penile cancer represents, to date, a rare oncological pathology (1/100000 males in Europe). However, in tertiary reference centres, such as the SCU Urologia (Prof. P.

Gontero), the number of patients sent for this pathology is increasing. Although for the main lesion (T) there are now consolidated standards of care, increasingly aimed at a conservative "sexual sparing" approach where oncologically possible, the management of loco-regional lymph nodes is still not completely standardized. The European Guidelines (EAU) recommend bilateral inguinal radical lymphadenectomy for cN1/N2 (palpable lymph nodes mono/bilaterally, but not fixed) or high-risk tumour (> T1G2). Lymph node management is the factor that most influences patient survival. For this reason, this must be entrusted to highly specialized centres. Some recent trials have shown that bilateral inguinal lymphadenectomy has a statistically significant superiority to radiotherapy and clinical surveillance in cN1/N2 patients. Despite this, inguinal lymphadenectomy has an important incidence of morbidity (up to 50% of cases) which often wrongly limits its indications. Main complications are: Lymphocele

• Prolonged lymphatic drainage
• Skin necrosis
• Dehiscence of the surgical wound
• Edema of lower limbs and genitals Only few studies have recently evaluated the oncological and functional results of inguinal lymphadenectomy performed with minimally invasive techniques using videolaparoscopic instruments. First results seem to support minimally invasive approach, that appears to have comparable oncological results and less post-operative morbidity.

However, evidences are still extremely limited, and no high-grade recommendations can be made. The aim of the present study is to prospectively compare oncological and functional results of penile radical inguinal lymphadenectomy performed with an open versus videolaparoscopic technique.

20 patients with indication for inguinal lymphadenectomy (according to EAU 2019 Guidelines - in case of primary lesion > pT1G2 or in case of lymph node disease cN1/N2) will be enrolled. Each patient will undergo treatment of the primary lesion and contextual inguinal lymphadenectomy. The procedure will be performed in this way: