Clinical trial · Interventional
Inguinal Lymphadenectomy for Penile Cancer
Inguinal Lymphadenectomy for Penile Cancer: an Interim Report From a Prospective Randomized Clinical Trial Comparing Open vs. Video-endoscopic Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Surgical Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inguinal Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open inguinal Lymphadenectomy
- description
- \- Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery
- interventionNames
- Procedure: Inguinal Lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic inguinal Lymphadenectomy
- description
- Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery
- interventionNames
- Procedure: Inguinal Lymphadenectomy
Primary outcomes (1)
- measure
- Surgical outcomes of lymph drainage (ml)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFalcone M, Gul M, Peretti F, Preto M, Cirigliano L, Scavone M, Sedigh O, Oderda M, Gontero P. Inguinal Lymphadenectomy for Penile Cancer: An Interim Report from a Trial Comparing Open Versus Videoendoscopic Surgery Using a Within-patient Design. Eur Urol Open Sci. 2024 Mar 21;63:31-37. doi: 10.1016/j.euros.2024.02.007. eCollection 2024 May. PMID 38558767