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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Surgery without trial (PJ) device
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.
Surgery with trial (PJ) device
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.
干预措施: PlasmaJet (Device)
结局指标
主要结局
Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment
时间窗: 24 months
次要结局
- Number of participants with treatment-related adverse events(Upto 1 year following surgery)
- Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs(Upto 1 year following surgery)
- Wound Infection(Upto 3months following surgery or till groins healed whichever is sooner)
- Length of Stay(Until 14 days following surgery)
- Lymphedema using the CTC V3.0 grading system(Upto two years following study entry)
研究者
Dr Thumuluru Kavitha Madhuri
Senior Clinical Fellow
Royal Surrey County Hospital NHS Foundation Trust