Expert review of medical devices · 2026
Efficacy of gradient compression sleeves in preventing postoperative upper extremity lymphoedema after breast cancer surgery.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Liao Yanyan, Chen Meijie, Ji Qiuchen, Jin Cuifeng, Zhu Xiaoyu, Xie Lijuan, Yang Weijuan, Wang Lili
Аннотация
BACKGROUND: Breast cancer-related lymphedema (BCRL) is a serious complication after breast cancer surgery. This study evaluated the efficacy of gradient compression sleeves in preventing BCRL.
RESEARCH DESIGN AND METHODS: In this prospective randomized controlled trial, 104 postmastectomy patients were randomized to conventional care (n = 52) or conventional care plus gradient compression sleeves (20-30 mmHg) for 12 months. The primary outcome was arm circumference change at 10 standardized sites measured at 90, 180, and 360 days post-surgery for evaluating efficacy. Secondary outcomes included Breast Cancer Lymphedema Symptom Experience Index (BCLE-SEI) for symptom severity and life impact for evaluating safety. Blinding of participants was not feasible due to the nature of the intervention.
RESULTS: The intervention group showed significantly smaller increases in arm circumference at multiple sites at 180 and 360 days (p < 0.05). BCLE-SEI scores for symptom severity and life impact were significantly lower in the intervention group (p < 0.05). No serious adverse events occurred; eight mild transient skin irritations were reported.
CONCLUSIONS: Prophylactic gradient compression sleeves may reduce BCRL progression and improve quality of life. Limitations include single-center design and lack of blinding.
REGISTRATION: ISRCTN registry (ISRCTN44170920).
RESEARCH DESIGN AND METHODS: In this prospective randomized controlled trial, 104 postmastectomy patients were randomized to conventional care (n = 52) or conventional care plus gradient compression sleeves (20-30 mmHg) for 12 months. The primary outcome was arm circumference change at 10 standardized sites measured at 90, 180, and 360 days post-surgery for evaluating efficacy. Secondary outcomes included Breast Cancer Lymphedema Symptom Experience Index (BCLE-SEI) for symptom severity and life impact for evaluating safety. Blinding of participants was not feasible due to the nature of the intervention.
RESULTS: The intervention group showed significantly smaller increases in arm circumference at multiple sites at 180 and 360 days (p < 0.05). BCLE-SEI scores for symptom severity and life impact were significantly lower in the intervention group (p < 0.05). No serious adverse events occurred; eight mild transient skin irritations were reported.
CONCLUSIONS: Prophylactic gradient compression sleeves may reduce BCRL progression and improve quality of life. Limitations include single-center design and lack of blinding.
REGISTRATION: ISRCTN registry (ISRCTN44170920).