NCT05592639

VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.

Detailed description

There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes. As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures. VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised

Conditions

• Penile Cancer
• Inguinal Lymphadenopathy
• Melanoma

Interventions

Type	Name	Description
PROCEDURE	Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy	Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.

Timeline

• Start date: 2022-06-23
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2022-10-25
• Last updated: 2025-05-16

Locations

1 site across 1 country: United Kingdom