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).

Autor: Tang S; University College London Hospitals NHS Trust, London, UK., Akers C; University College London Hospitals NHS Trust, London, UK., Alnajjar H; University College London Hospitals NHS Trust, London, UK., Ayres B; St George's University Hospitals NHS Trust, London, UK., Baldini C; University College London, London, UK., Embleton-Thirsk A; University College London, London, UK., Gurusamy K; University College London, London, UK., Hadway P; Royal Berkshire NHS Foundation Trust, Reading, UK., Kumar V; Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK., Lau M; The Christie NHS Foundation Trust, Manchester, UK., Nigam R; Royal Surrey County Hospital, Surrey, UK., Pang K; University College London Hospitals NHS Trust, London, UK., Parnham A; The Christie NHS Foundation Trust, Manchester, UK., Pizzo E; University College London, London, UK., Ranieri V; University College London, London, UK., Rees R; University Hospital Southampton NHS Foundation Trust, Southampton, UK., Sangar V; The Christie NHS Foundation Trust, Manchester, UK., Wadke A; University College London, London, UK., Williams N; University College London, London, UK., Muneer A; University College London Hospitals NHS Trust, London, UK. asif.muneer@nhs.net.
Jazyk: angličtina
Zdroj: Pilot and feasibility studies [Pilot Feasibility Stud] 2024 Apr 10; Vol. 10 (1), pp. 61. Date of Electronic Publication: 2024 Apr 10.
DOI: 10.1186/s40814-024-01474-8
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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