VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Penile Cancer, Inguinal Lymphadenopathy, Melanoma

Intervention / Treatment
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* Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People requiring inguinal lymphadenectomy i.e. Patients with squamous cell carcinoma or mucosal melanoma of the penis > T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy Small volume palpable inguinal lymph nodes (< 2 cm on CT) not fixed to skin Age > 18 years Exclusion Criteria: Unfit for surgery People unlikely to benefit from lymphadenectomy because of advanced cancer Those with palpable inguinal lymph nodes fixed to skin or adjacent structures Does not want to participate in the trial or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Videoendoscopic Inguinal Lymphadenectomy<br>Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy | Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy<br>* Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.<br>|
| Other: Open Inguinal Lymphadenectomy<br>Removal of inguinal nodes using Open radical inguinal lymphadenectomy | Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy<br>* Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to recruit patients | Ability to recruit patients at the selected sites (recruitment rate) | 18 months |