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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vulvar Cancer, Groin Node

Intervention / Treatment
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* Device: PlasmaJet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Surgery without trial (PJ) device<br>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. | |
| Active Comparator: Surgery with trial (PJ) device<br>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. | Device: PlasmaJet<br>* The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | To document the side-effect profile post-operatively following surgery with the PJ device. | Upto 1 year following surgery | 
| Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs | 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 | Upto 1 year following surgery | 
| Wound Infection | Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed | Upto 3months following surgery or till groins healed whichever is sooner | 
| Length of Stay | Length of hospital stay following surgery will be recorded as well as any readmissions | Until 14 days following surgery | 
| Lymphedema using the CTC V3.0 grading system | Grade of lymphedema to be assessed at each clinic visit for two years following surgery | Upto two years following study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea