Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer
Vulvar Cancer, Groin Node
About this trial
This is an interventional treatment trial for Vulvar Cancer focused on measuring vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea
Eligibility Criteria
Inclusion Criteria:
- To be included in this study, all women should undergo BGND during their treatment pathway for histologically confirmed vulval cancer.
- Participant is willing and able to provide informed consent.
- Aged 18 years or above.
- Participant willing to allow General Practitioner and other health care professionals, if appropriate, to be notified of participation in study.
Exclusion Criteria:
- Women with vulval cancer who do not undergo BGND.
- Women with any previous groin surgery
- Women with any previous radiotherapy to the pelvic area including the groins
- Patient choice
- Women who are pregnant, lactating or planning pregnancy during the course of the study
Sites / Locations
- Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Surgery without trial (PJ) device
Surgery with trial (PJ) device
All steps of surgery are conducted as per standard practice in accordance with the current practice at the time. In all cases a bilateral inguino-femoral groin node dissection was performed, with en-bloc removal of the superficial and deep inguinal nodes with conservation of the long saphenous vein.
Use of the PJ was limited to the randomised side only. All steps of surgery are conducted as per standard practice in accordance with the current practice at the time. In all cases a bilateral inguino-femoral groin node dissection was performed, with en-bloc removal of the superficial and deep inguinal nodes with conservation of the long saphenous vein. Haemostasis was ensured with diathermy and ties and just prior to wound closure, the surgeon used the PlasmaJet on the indicated groin to seal the lymph vessels and channels at a setting of 40% by spraying the argon plasma over the entire exposed surgical field at a distance of 10 mm from the surface to the tip of the instrument.