Objectives: Leg lymphedema remains a significant health problem after treatment of vulval cancer. This pilot study explored the feasibility of conducting a larger trial to investigate whether the early use of compression stockings is effective in preventing leg lymphedema.
Methods: Fourteen patients undergoing inguinofemoral lymphadenectomy for vulval cancer were randomized to either best supportive care or best supportive care plus the use of graduated compression stockings for 6 months.
Results: Six of 7 patients in the treatment group complied with the study protocol. The incidence of clinically significant lymphedema was not different between both groups; however, there was a greater increase in mean leg volume in the control group (953 vs 607 mL, P = 0.010). Furthermore, patients in the treatment group showed better performance as judged by leg symptoms (P = 0.031, at 3 months) and clinical examination (P = 0.039 at 4 weeks and P = 0.004 at 6 months). There was no difference in the incidence of groin wound dehiscence, infection, or lymphocyst formation. We detected no difference between both groups' scores when using a validated quality-of-life questionnaire. Intraobserver and interobserver variabilities of leg-volume measurement technique were investigated using the principles of repeatability and reproducibility statistics. Intraobserver variability was estimated at 270 mL, whereas interobserver variability was 1000 mL.
Conclusions: The prophylactic use of stockings in this population is feasible, and further larger studies are justified to investigate its role in reducing the incidence of leg lymphedema. The design of these studies should take into account the observer-related variability in measuring leg volume or consider alternative methods.
- Vulval cancer
- Compression stockings
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