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Inguinal Lymphadenectomy for Penile Cancer

NCT05887921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-06-05

No results posted yet for this study

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.

Conditions

  • Penile Cancer
  • Lymph Node Metastasis
  • Sentinel Lymph Node
  • Surgical Complication

Interventions

PROCEDURE

Inguinal Lymphadenectomy

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

Sponsors & Collaborators

  • A.O.U. Città della Salute e della Scienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2022-12-22
Completion
2023-05-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05887921 on ClinicalTrials.gov