Background <p>Lymphedema is a common and burdensome complication after groin dissection for metastatic melanoma. This study evaluated whether a 6-month program of compression garments combined with simple lymphatic drainage (CG-SLD) reduces the rate of lymphedema presentation compared with standard care (SC).</p> Patients and Methods <p>Participants were randomized 1:1 to SC or CG-SLD for 6 months postoperatively. Lymphedema was assessed preoperatively and every 3 months for 24 months using interlimb volume difference and bioimpedance spectroscopy. The primary end point was the incidence of lymphedema at 24 months. Secondary outcomes included time to lymphedema development, lymphedema severity, and quality of life (QoL). The study was powered to detect a reduction in 24 month incidence from 45 to 18% (<i>α</i> = 0.05, 80% power), requiring 88 participants.</p> Results <p>A total of 38 participants were randomized (SC <i>n</i> = 20; CG-SLD <i>n</i> = 18), below the planned sample size. At 24 months, lymphedema incidence was numerically higher but nonsignificant for SC compared with CG-SLD; 55% (31.5–76.9) versus 38.9% (17.3–64.3). All new lymphedema events occurred within 12 months. Early lymphedema severity at 3 months favored CG-SLD; however, no persistent between-group differences were observed at later time points. There was no statistical evidence to support a difference in QoL scores at any time point.</p> Conclusions <p>CG-SLD did not reduce lymphedema incidence compared with SC at 24 months. Although early reductions in lymphedema incidence and severity were observed for CG-SLD, these were not maintained beyond 6 months when interventions ceased. The study was underpowered, and larger trials are required to determine whether early prophylactic strategies provide durable benefit.</p>

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Minimizing Early-Onset Lymphedema Following Groin Dissection in Metastatic Melanoma

  • Melody Brown,
  • Teresa S. Lee,
  • Isabel Li,
  • Christopher Allan

摘要

Background

Lymphedema is a common and burdensome complication after groin dissection for metastatic melanoma. This study evaluated whether a 6-month program of compression garments combined with simple lymphatic drainage (CG-SLD) reduces the rate of lymphedema presentation compared with standard care (SC).

Patients and Methods

Participants were randomized 1:1 to SC or CG-SLD for 6 months postoperatively. Lymphedema was assessed preoperatively and every 3 months for 24 months using interlimb volume difference and bioimpedance spectroscopy. The primary end point was the incidence of lymphedema at 24 months. Secondary outcomes included time to lymphedema development, lymphedema severity, and quality of life (QoL). The study was powered to detect a reduction in 24 month incidence from 45 to 18% (α = 0.05, 80% power), requiring 88 participants.

Results

A total of 38 participants were randomized (SC n = 20; CG-SLD n = 18), below the planned sample size. At 24 months, lymphedema incidence was numerically higher but nonsignificant for SC compared with CG-SLD; 55% (31.5–76.9) versus 38.9% (17.3–64.3). All new lymphedema events occurred within 12 months. Early lymphedema severity at 3 months favored CG-SLD; however, no persistent between-group differences were observed at later time points. There was no statistical evidence to support a difference in QoL scores at any time point.

Conclusions

CG-SLD did not reduce lymphedema incidence compared with SC at 24 months. Although early reductions in lymphedema incidence and severity were observed for CG-SLD, these were not maintained beyond 6 months when interventions ceased. The study was underpowered, and larger trials are required to determine whether early prophylactic strategies provide durable benefit.