Lymphoedema Prevention Following Inguinal or Ilioinguinal Dissection for Metastatic Melanoma
Are compression garments and manual lymphatic drainage more effective than no compression or drainage in reducing the incidence/severity of lymphoedema in patients with metastatic melanoma (Stage III), following inguinal or ilioinguinal dissection?
Mater Health Services
155 participants
Jul 24, 2012
Interventional
Conditions
Summary
This study aims to determine whether compression garments and self massage can prevent or reduce lymphoedema (fluid retention) following groin dissection for metaststic melanoma. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years and over with confirmed metastatic melanoma. You should be able to attend regular follow-up appointments over a period of 2 years. Trial details. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will wear compression stockings 12 hours a day for 6 months and conduct daily self massage for a period of 6 months following post operative removal of drains. Participants in this group will receive 1:1 training in self massage over 3 half hour sessions. They will also receive education and training to ensure they (or their carer) are able to safely put on and remove the compression garment. Participants in the other group will be monitored via 3 monthly assessments. If lymphoedema arises, they will be offered comprehensive treatment (as is standard treatment). All participants will be assessed every 3 months to determine the incidence/severity of lymphoedema and quality of life, and whether this differs between groups.
Eligibility
Inclusion Criteria6
- 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)
Exclusion Criteria4
- Peripheral arterial disease (ABPI <.6)
- Pre-existing lymphoedema
- Bilateral groin dissection
- Previous contralateral groin dissection
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Interventions
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.
Locations(1)
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ACTRN12612000005853