An investigation into the possible benefits to the reduction of lymph drainage following groin surgery for treatment of vulvar cancer using a new device (PlasmaJet) during surgery

A prospective, randomised, crossover, feasibility study to evaluate the utility and efficacy of PlasmaJet as a new technology to assist in the management of lymphedema and lymphocyst formation by improving drainage of lymphatic fluid (lymphostasis) and coagulation (haemostasis) in patients undergoing bilateral groin node dissection (BGND) for vulval cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46571788

Enrollment

Registered

2019-02-19

Start date

2013-01-01

Completion date

Unknown

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with vulvar cancer undergoing groin node dissection Surgery

Interventions

The PlasmaJet device is used following groin node dissection on the side randomised to receive it (as per protocol specifications)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Due to undergo BGND during their treatment pathway for histologically confirmed vulval cancer 2. Willing and able to provide informed consent 3. Aged 18 years or above 4. Willing to allow General Practitioner and other health care professionals, if appropriate, to be notified of participation in the study

Exclusion criteria

Exclusion criteria: 1. Women with vulval cancer who do not undergo BGND 2. Previous groin surgery 3. Previous radiotherapy to the pelvic area including the groins 4. Pregnant, lactating or planning pregnancy during the course of the study 5. Not willing to participate

Design outcomes

Primary

Measure	Time frame
The feasibility of a crossover (split body) double-blind RCT using an interventional device (PJ) in women undergoing BGND for vulvar cancer surgery. Measured by the number of patients recruited, number of patients declining participation and reason for decline if any exists. Assessed at end of study.	—

Secondary

Measure	Time frame
1. 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, recorded daily in patient records 2. The side-effect profile post-operatively following surgery with the PJ device. Recorded in the operating notes and post-operatively in the patient records 3. Wound infection rates, recorded daily in patient records while in hospital and in the clinic notes following discharge till the wound has healed completely. 3. Hospital readmission rates, recorded daily in patient records while in hospital and in the clinic notes following discharge till the wound has healed completely. 4. Lymphoedema rates, recorded at every clinic visit for 2 years following last patient recruitment.	—

Measure

Time frame

1. 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, recorded daily in patient records 2. The side-effect profile post-operatively following surgery with the PJ device. Recorded in the operating notes and post-operatively in the patient records 3. Wound infection rates, recorded daily in patient records while in hospital and in the clinic notes following discharge till the wound has healed completely. 3. Hospital readmission rates, recorded daily in patient records while in hospital and in the clinic notes following discharge till the wound has healed completely. 4. Lymphoedema rates, recorded at every clinic visit for 2 years following last patient recruitment.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026