Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05887921 |
| Other study ID # |
00025/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2019 |
| Est. completion date |
May 24, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
