Inguinal Lymphadenectomy for Penile Cancer
Condition: Penile Cancer; Lymph Node Metastasis; Sentinel Lymph Node; Surgical Complication
MeSH terms: Lymphatic Metastasis; Penile Neoplasms
Study type: Interventional

Summary: 
      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.

      The main questions it aims to answer are: evaluated the oncological and functional results of
      inguinal lymphadenectomy performed with minimally invasive techniques using videolaparoscopic
      instruments vs open inguinal lymphadenectomy according to the standard technique.

      Participants will undergo treatment of the primary lesion and contextual inguinal
      lymphadenectomy:

        -  Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in
           traditional surgery

        -  Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive
           experience in minimally invasive surgery. The results of these procedures will be
           prospectively collected and compared.
    

Detailed description: 
      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:

        -  Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in
           traditional surgery

        -  Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive
           experience in minimally invasive surgery The results of these procedures will be
           prospectively collected and compared. The main outcome will be the percentage of
           postoperative complications (lymphocele, prolonged lymph drainage, necrosis of the skin,
           dehiscence of the surgical wound, edema of lower limb, emergency admission from the ED,
           re-intervention/surgical revision).

      Complications will be classified according to the international Clavien-Dindo classification.
      Additionally, secondary outcomes (number of lymph nodes, number of positive lymph nodes,
      surgical time) will be evaluated. After the operation, patients will attend a 24-month
      follow-up program, as reported in the flow chart, functional results and patient satisfaction
      will be evaluated during the visits.

      The categorical variables will be described using frequency and percentage, and the
      continuous variables will be described using median and interquartile range (IQR) value.

      Differences between groups will be assessed by the Student independent t test or the
      Mann-Whitney U test on the basis of their normal or not-normal distribution, respectively
      (normality of variables' distribution will be tested by the Kolmogorov-Smirnov test).
    

Intervention name(s): Inguinal Lymphadenectomy
Intervention type(s): Procedure
Intervention description(s): arm A: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery arm B: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Surgical, observational, prospective, monocentric study.
Masking: None (Open Label)
Primary purpose: Treatment