Videoendoscopic radical inguinal lymphadenectomy for penile cancer
Research type
Research Study
Full title
Videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer: a feasibility randomised controlled trial
IRAS ID
278078
Contact name
Asif Muneer
Contact email
Sponsor organisation
Joint Research Office, UCL
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2020/04/120, UCL Data Protection Office
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
As part of treatment of penile and urethral cancers, 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.
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. The only previous RCT comparing the procedures for other indications was conducted in USA and could not recruit sufficient people because of patient preference for VEIL. However, this could be because of the way the participants were provided the information.
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.
Fifty patients will take part in this study; half will be randomised to VEIL and others will undergo open surgery. Participants will be followed up for 6 months. Half will undergo VEIL while the other half will undergo open surgery. 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’).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0216
Date of REC Opinion
5 Oct 2021
REC opinion
Favourable Opinion