RecruitingACTRN12612000005853

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?

Sponsor

Mater Health Services

Enrollment

155 participants

Start Date

Jul 24, 2012

Study Type

Interventional

Conditions

Lymphoedema following inguinal or ilioinguinal groin dissection for metastatic melanoma

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether wearing a compression stocking and doing daily self-massage can prevent lymphoedema (fluid build-up causing swelling) in the leg after surgery to remove lymph nodes in the groin for metastatic melanoma. Lymphoedema is a common and distressing complication of this surgery. Participants are randomly assigned to either wear compression stockings and learn self-massage for 6 months, or to receive standard monitoring and treatment only if lymphoedema develops. You may be eligible if: - You are 18 years or older - You have confirmed metastatic melanoma - You are able to attend follow-up appointments every 3 months for 2 years - You (or a carer) are able to apply and remove the compression garment and perform simple lymphatic drainage massage - You speak English or have an interpreter available You may NOT be eligible if: - You have peripheral arterial disease (poor blood supply to the legs) - You already have lymphoedema in the affected leg - You are having groin dissection on both sides at once - You have had a previous groin dissection on the other side Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Th

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)

QLD, Australia

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ACTRN12612000005853