Condition category
Surgery
Date applied
11/02/2019
Date assigned
19/02/2019
Last edited
22/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When lymph nodes are removed from the female groin area as part of treatment for vulval cancer, occasionally collections of fluid (lymph) can occur in the area where the lymph nodes were present. These collections are called lymphocysts. In most cases they eventually get absorbed and resolve by themselves but occasionally they need to be drained repeatedly with needles over a period of few weeks.
Groin lymphocyst formation occurs in aprroximately 10% patients undergoing surgery for vulval cancer and all problems including wound infections, breakdown of wounds occur in nearly 50% of cases. It can cause physical symptoms like pain, swelling around the groin area, leaking of lymph fluid and infections. It is emotionally very distressing for the patient requiring frequent hospital attendances and treatment.
PlasmaJet® is a new device which has been reported to reduce the formation of lymph in surgical wounds and we would like to investigate its usefulness in reducing the chance of groin lymphocyst formation and other complications if it is used in the surgery to remove the lymph glands.
The aim of our study is to assess the potential and safety of using The PlasmaJet technology in the prevention of groin lymphocyst (collection of lymph fluid in the groin) formation by sealing tissues or to burn away thin layers of tissue in patients undergoing BGND for vulval cancer.

Who can participate?
Women over the age of 18 with a confirmed diagnosis of vulvar cancer and requiring removal of lymph glands on both sides of their groins are eligible to participate

What does the study involve?
Each patient will have one side of their groin treated with standard surgery and the other side will be treated using standard surgery followed by the PlasmaJet device.

What are the possible benefits and risks of participating?
The study is exploring if the PlasmaJet device offers any benefit in terms of reduction in the number of complications. The device is known to be safe and there are no known risks from participation.

Where is the study run from?
The Royal Surrey County Hospital NHS Foundation Trust in Guildford, Surrey.

When is the study starting and how long is it expected to run for?
August 2013 to August 2016

Who is funding the study?
The study is being supported by “GRACE” charity (https://www.grace-charity.org.uk/)

Who is the main contact?
Dr Thumuluru Kavitha Madhuri
tmadhuri@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thumuluru Kavitha Madhuri

ORCID ID

http://orcid.org/0000-0002-9591-8441

Contact details

Department of Gynaecological Oncology
LEVEL B GOPD Outpatients 1
Royal Surrey County Hospital NHS Foundation Trust
Guildford
GU2 7XX
United Kingdom
+44 (0)1483 571122
tmadhuri@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PJBGND

Study information

Scientific title

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.

Acronym

PJBGND

Study hypothesis

To evaluate the ability of PJ to reduce complications in women undergoing groin node dissection for vulvar cancer

Ethics approval

Approved 02/01/2009, Surrey Research Ethics Committee (Royal Surrey County Hospital, GU2 7XX; 0207 1048058, NRESCommittee.SECoast-Surrey@nhs.net), ref: 09/H1109/71

Study design

Pilot randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Women with vulvar cancer undergoing groin node dissection

Intervention

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

Intervention type

Device

Phase

Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date

01/07/2013

Overall trial end date

01/07/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

25

Participant 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

Recruitment start date

01/01/2013

Recruitment end date

01/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom

Sponsor information

Organisation

Royal Surrey County Hospitals NHS Foundation Trust

Sponsor details

Research & Development Department
Guildford
GU2 7XX
United Kingdom
+44 (0)1483571122
rsc-tr.ResearchAndDevelopment@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

GRACE Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study will be published in high-impact peer-reviewed medical journals by 01/07/2019. In view of the small number of participants, each patient will be contacted and offered an opportunity to discuss the results.
GRACE is scheduling a focus group of patients and we also have plans to disseminate the overview of findings in the local newspapers

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/07/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/02/2019: Internal review.