Prevenção de linfedema após linfadenectomia pélvica estendida usando diosmina, bromelaína, meliloto e hesperidina: resultados de um estudo prospectivo randomizado (ensaio PRELYNE)

Resumo original em inglês

O que aconteceu

Extended pelvic lymph node dissection (ePLND) during robot-assisted radical prostatectomy (RARP) may impair lymphatic drainage, causing lower-limb and genital lymphedema with a potential negative impact on postoperative recovery and quality of life. This prospective randomized study evaluated whether an oral formulation containing diosmin, bromelain, melilotus, and hesperidin (Meliven Top®) could reduce postoperative lymphatic morbidity after RARP with ePLND. One hundred patients undergoing RARP with ePLND for prostate cancer were randomized 1:1 to standard postoperative care alone or standard care plus oral Meliven Top® for one month. Lower-limb volumes were assessed preoperatively and at 1 and 3 months postoperatively using circumferential measurements and truncated-cone volume estimation. Secondary endpoints included genital swelling, genital pain, and lymphocele formation. Multivariable ANCOVA models adjusted for baseline limb volume, body mass index, and number of lymph nodes removed were applied.Ninety-eight patients completed follow-up. No significant differences in lower-limb volumetric changes were observed between groups at 1 or 3 months. However, genital pain at 1 month was significantly lower in the treatment group (2% vs. 18%; p = 0.008), and persistent genital swelling at 3 months was absent in treated patients compared with controls (0% vs. 8%; p = 0.041). Lymphocele rates were similar between groups. In conclusion, Meliven Top® did not significantly reduce postoperative lower-limb volume changes after RARP with ePLND, but it was associated with improved genital symptom recovery. Larger studies with longer follow-up are warranted.Clinical trial registration This study was not registered in a public clinical trial registry.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.