Lymphoedema Prevention Following Inguinal or Ilioinguinal Dissection for Metastatic Melanoma

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: Thigh length, 20‐30mmHg compression garments on the leg of the operative side, and medical grade compression shorts will be worn approximately 12 hours a day and removed for hygienne and sleeping. The specific garment utilised will depend on the individual patient measurements regarding best fit and fabric characteristics so may include garments from Sigvaris, Jobst, Juzo or if required, even be custom made. Unless medical co‐morbidities dictate caution, all leg garments will be 20‐30mmHg. All garments will be applied following removal of post operative drains. Simple, or self lymphatic drainage (SLD) will be taught to participants in the intervention group by trained lymphoedema therapists. They will be provided an individual body map and drainage pathway and guidelines. They will receive three half hour formal 1:1 education sessions regarding self lymphatic drainage and are asked to conduct this each day for 6 months following post operative removal of drains. Training and education regarding correct garment donning and doffing of garments will occur at initial fitting with trained lymphoedema therapists ensuring that the participant (or carer) are able to correctly and safely apply and remove the garments. Drainage techniques and garment wear will continue to be assessed and monitored throughout the 6 month intervention phase. CONDITION: Lymphoedema following inguinal or ilioinguinal groin dissection for metastatic melanoma PRIMARY OUTCOME: Reduction in the rate of lymphoedema of 45% to 18% with statistical significance of p = 0.05. Allowing for a 33% two year mortality and 10% attrition a total of 155 participants need to be recruited to the study in order to achieve a sample of size of 88. ; There is no worldwide consensus regarding quanitification of lymphoedema and this creates problems for classifying lymphoedema. ; For the purpose of this study, our team have defined lymphoedema as a volume change of greater than 10% compared to the unaffected limb in addition to a bioimpedance change of 10 points from pre‐operative baseline. The International Society of Lymphology defines "mild" lymphoedema as less than a 20% volume change. ; Circumferential tape measurements at 10cm intervals (using a measuring board) will be taken of the operated side and contralateral leg. In addition, bioimpedence analysis will also be taken. ; Quality of Life self rating scales (EORTC and the LYMQOL‐leg) will also be utilised. ; Assessments will be conducted by a blinded assessor pre‐operatively, at 6 weeks post operatively and then at 3 monthly intervals for 2 years following surgery. SECONDARY OUTCOME: Assess quality of life for all patients. ; ; EORTC and the LYMQOL (leg) will be administered to control and intervention groups to assess quality of life. Assessing the impact of the following in development of lymphoedema (seroma, wound complications, co‐morbidities, BMI, adjuvant radiotherapy). ; ; ; Whilst evidence exists to support that increased BMI and radiotherapy may negatively impact on development of lymphoedema, we wish to analyse whether the number of pre‐existing co‐morbidities OR wound complications further contribue to lymphoedema development. Reduction in severity of lymphoedema between groups. ; ; This will be quantified by the volume of lymphoedema measured using both circumferential measures to calculate volume and using bioimpedence measures. ; ; LYMQOL‐leg is a self‐rating questionaire asking patients to quantify their perception of how lymphoedema is impacting on their life and function. INCLUSION CRITERIA: Aged 18 years and over English speaking (or interpreter available) Ability to provide informed consent Ability to attend regular followup Confirmed metastatic melanoma Ability to apply and remove garment, conduct simple lymphatic drainage (or carer available to do so)
Epistemonikos ID: 79332fc2b31375b89abca06d26e668861253222e
First added on: Aug 25, 2024