NCT04105465

Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Cancer
• Groin Node

Interventions

Type	Name	Description
DEVICE	PlasmaJet	The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2019-09-26
• Last updated: 2019-09-27

Locations

1 site across 1 country: United Kingdom