Tang, S;
Akers, C;
Alnajjar, H;
Ayres, B;
Baldini, C;
Embleton-Thirsk, A;
Gurusamy, K;
Hadway, P;
Kumar, V;
Lau, M;
et al.
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
(2024)
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, 10 (1).
p. 61.
ISSN 2055-5784
https://doi.org/10.1186/s40814-024-01474-8
SGUL Authors: Ayres, Benjamin
|
PDF
Published Version
Available under License Creative Commons Attribution. Download (956kB) | Preview |
|
![]() |
Microsoft Word (.docx) (Supplementary material 1)
Supplemental Material
Available under License Creative Commons Attribution. Download (30kB) |
Abstract
BACKGROUND: Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients with impalpable disease. However, radical inguinal lymphadenectomy is associated with a high morbidity rate, and there is increasing usage of a videoendoscopic approach as an alternative. METHODS: A pragmatic, UK-wide multicentre feasibility randomised controlled trial (RCT), comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy. Patients will be identified and recruited from supraregional multi-disciplinary team meetings (sMDT) and must be aged 18 or over requiring inguinal lymphadenectomy, with no contraindications to surgical intervention for their cancer. Participants will be followed up for 6 months following randomisation. The primary outcome is the ability to recruit patients for randomisation across all selected sites and the rate of loss to follow-up. Other outcomes include acceptability of the trial and intervention to patients and healthcare professionals assessed by qualitative research and obtaining resource utilisation information for health economic analysis. DISCUSSION: There are currently no other published RCTs comparing videoendoscopic versus open radical inguinal lymphadenectomy. Ongoing study is required to determine whether randomising patients to either procedure is feasible and acceptable to patients. The results of this study may determine the design of a subsequent trial. TRIAL REGISTRATION: Clinicaltrials.gov PRS registry, registration number NCT05592639. Date of registration: 13th October 2022, retrospectively registered.
Item Type: | Article | ||||||
---|---|---|---|---|---|---|---|
Additional Information: | © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | ||||||
Keywords: | Lymphadenectomy, Melanoma, Penile cancer, Squamous cell carcinoma, Penile cancer, Lymphadenectomy, Squamous cell carcinoma, Melanoma | ||||||
SGUL Research Institute / Research Centre: | Academic Structure > Institute of Medical & Biomedical Education (IMBE) Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE ) |
||||||
Journal or Publication Title: | Pilot Feasibility Stud | ||||||
ISSN: | 2055-5784 | ||||||
Language: | eng | ||||||
Dates: |
|
||||||
Publisher License: | Creative Commons: Attribution 4.0 | ||||||
Projects: |
|
||||||
PubMed ID: | 38600541 | ||||||
Web of Science ID: | WOS:001199961400002 | ||||||
Go to PubMed abstract | |||||||
URI: | https://openaccess.sgul.ac.uk/id/eprint/116769 | ||||||
Publisher's version: | https://doi.org/10.1186/s40814-024-01474-8 |
Statistics
Actions (login required)
![]() |
Edit Item |