Inguinal Lymphadenectomy for Penile Cancer

Study Overview
=================
Brief 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).

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

Conditions
-----------------
Penile Cancer, Lymph Node Metastasis, Sentinel Lymph Node, Surgical Complication

Intervention / Treatment
-----------------
* Procedure: Inguinal Lymphadenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of patients [45-80], CCI ≤ 3. Penile tumour with inguinal lymphadenectomy indication, according to EAU 2019 guidelines. Written informed consent. Exclusion Criteria: Age of patients> 80, CCI ≥ 3. Patients with lymphatic disorders of lower limbs. Patients with previous inguinal surgery/radiotherapy. Previous or concomitant diagnosis of other tumours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Surgical, observational, prospective, monocentric study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open inguinal Lymphadenectomy<br>- Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery | Procedure: Inguinal Lymphadenectomy<br>* 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<br>|
| Active Comparator: Laparoscopic inguinal Lymphadenectomy<br>Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery | Procedure: Inguinal Lymphadenectomy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes of lymph drainage (ml) | Stratification of complications according to the international classification of Clavien-Dindo. | 24 months |