Groin Node, Vulvar Cancer
Conditions
Keywords
vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea
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.
Interventions
DEVICEPlasmaJet
The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
A double blind system was applied. Since randomisation was performed in theatre, the patient was unaware of the side that the PJ device was applied. This was not mentioned in the operation notes either. As a result, the nursing team on the inpatient ward were also blinded to the randomisation.
Intervention model description
The trial design was conceived as a single site, double blind, crossover study in which each patient would be their own control would offer the most useful information.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | Upto 1 year following surgery | To document the side-effect profile post-operatively following surgery with the PJ device. |
| Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs | Upto 1 year following surgery | To explore the potential and safety of the PJ device in the prevention of groin lymphocyst formation by prophylactic coagulation of lymph vessels in patients undergoing BGND for vulval cancer |
| Wound Infection | Upto 3months following surgery or till groins healed whichever is sooner | Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed |
| Length of Stay | Until 14 days following surgery | Length of hospital stay following surgery will be recorded as well as any readmissions |
| Lymphedema using the CTC V3.0 grading system | Upto two years following study entry | Grade of lymphedema to be assessed at each clinic visit for two years following surgery |
Countries
United Kingdom
Outcome results
None listed