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Acerca de

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Cancers of penis and urethra (outlet for passing urine)are rare male genital cancers (600 new cases and 134 deaths annually in UK). As part of the treatment, patients may require an operation called ‘radical inguinal lymphadenectomy’, a procedure to remove groin lymph nodes. This is a major surgical procedure and is usually performed as an open operation: 20% to 60% of patients develop complications, some of which lead to long- standing pain and disfigurement.

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Video endoscopic inguinal lymphadenectomy (VEIL) is a relatively new minimally invasive procedure in which the groin lymph nodes are removed using key hole surgery. VEIL may have fewer overall complications than open surgery, although some complications may be more common such as ‘lymphoecoele’ (collection of lymph under the skin). This can sometimes cause pain and require additional treatments. Furthermore, there is uncertainty about whether the reduction in complications in VEIL is because of careful selection of patients and whether the cancer recurrence is similar in VEIL as in open surgery. This uncertainty can only be resolved through a well- designed randomised controlled trial (RCT), a type of study which ensures that similar types of patient receive VEIL and open surgery. A previous RCT in USA comparing the two procedures for mainly skin cancers could not recruit sufficient people because of patient preference for VEIL. The method of presenting the trial to participants and participants’ understanding of the trial could be one of the major reasons for poor recruitment despite the uncertainty about long-term cancer recurrence. There are no other published or ongoing RCTs comparing VEIL versus open surgery.

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The aim of this research is to find out whether it is possible to conduct a RCT to compare VEIL versus open inguinal lymphadenectomy in patients diagnosed with penile cancer.

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Fifty patients will take part in this study and will be followed up for 6 months. Half will undergo VEIL while the other half will undergo open surgery. Participants in each group will be chosen by the study. This study will look at whether this type of study is acceptable to patients and clinicians and will help design a larger trial (‘definitive RCT’) to find out if VEIL or open surgery is better for patients and NHS.

Trial details

Lead Applicant

Mr Asif Muneer

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Title

Videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer: a feasibility randomised controlled trial

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Reference

NIHR200765

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Organisation

University College London Hospitals NHS Foundation Trust

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Co-Applicants

Mr Jeff Addison
Miss Clare Akers
Dr Andrew Embleton-Thirsk
Professor Kurinchi Gurusamy
Mr Vivekanandan Kumar
Mr Arie Parnham
Dr Elena Pizzo
Dr Veronica Ranieri
Professor Norman Williams

Grant Manager

Jennie Hejdenberg

  

Master Grant Type

RfPB

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Start Date

02 August 2021

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Duration

36 months

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Current End Date

01 August 2024

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