Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Christie NHS Foundation Trust | OTHER |
| St George's University Hospitals NHS Foundation Trust | OTHER |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videoendoscopic Inguinal Lymphadenectomy | Active Comparator | Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy |
|
| Open Inguinal Lymphadenectomy | Other | Removal of inguinal nodes using Open radical inguinal lymphadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy | Procedure | Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to recruit patients | Ability to recruit patients at the selected sites (recruitment rate) | 18 months |
Not provided
Not provided
Inclusion Criteria:
People requiring inguinal lymphadenectomy i.e.
Age > 18 years
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Asif Muneer, MD | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London | London | London | NW1 2BU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38600541 | Derived | Tang S, Akers C, Alnajjar H, Ayres B, Baldini C, Embleton-Thirsk A, Gurusamy K, Hadway P, Kumar V, Lau M, Nigam R, Pang K, Parnham A, Pizzo E, Ranieri V, Rees R, Sangar V, Wadke A, Williams N, Muneer A. A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD). Pilot Feasibility Stud. 2024 Apr 10;10(1):61. doi: 10.1186/s40814-024-01474-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010412 | Penile Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |