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Brief Title: Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer
Official Title: Randomised,Crossover, Feasibility Study to Evaluate the PlasmaJet in the Management of Lymphedema and Lymphocyst Formation in Patients Undergoing Bilateral Groin Node Dissection (BGND) for Vulval Cancer
Study ID: NCT04105465
Brief Summary: Surgery for vulvar cancer involves removal of the central tumour as well as groin node dissection as indicated depending on the stage of tumour. Groin node dissection is associated with significant complications including lymphorrea, lymphocyst formation, wound breakdown as well as long term complications including lymphedema. This study has been designed with each patient acting as their own control to investigate if using the PlasmaJet during surgery is associated with a reduction in the above mentioned complications.
Detailed Description: Vulvar malignancy is the fourth most common malignancy of the female genital tract. Surgical excision achieves excellent local control and remains the mainstay of treatment. Surgical excision depends on the extent of disease and may be in the form of wide local excision or radical vulvectomy. Lymphadenectomy in the form of bilateral groin node dissection (BGND) is performed for all central tumors with depth of invasion greater than 1 mm, unless there is significant comorbidity contraindicating this, but is known to cause significant postoperative morbidity. Immediate postoperative complications include breakdown and lymphocyst formation in more than 50% of cases. The PlasmaJet is a novel device that produces a jet of pure argon plasma by heating pressurized argon gas. Energy from the argon plasma transfers to tissue as light, heat, and kinetic energy. Following ethical approval, a prospective, crossover, doubleblind, randomized, control trial to assess the PJ system, with the primary outcome being the possibility of reduction in wound breakdown and lymphocyst and lymphedema formation following BGND for vulvar cancer was opened.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust, Guildford, Surrey, United Kingdom
Name: Thumuluru K Madhuri, MD
Affiliation: Royal Surrey County Hospitals NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR