Section of oncologic plastic surgery, Department of Plastic and Reconstructive Surgery, Oslo University Hospital Radiumhospitalet, Oslo, Norway.
Section of oncologic plastic surgery, Department of Plastic and Reconstructive Surgery, Oslo University Hospital Radiumhospitalet, Oslo, Norway.
J Surg Res. 2021 Nov;267:467-476. doi: 10.1016/j.jss.2021.05.005. Epub 2021 Jul 7.
The complication rate after axillary lymph node dissection (ALND) and inguinal lymph node dissection (ILND) in melanoma patients is high. The aim of this randomized non-inferiority study was to evaluate the effect of postoperative wound drainage on early complications after ALND and ILND.
Between 2018 and 2020, 104 stage III melanoma patients operated on with ALND or ILND were randomized to a study group with complete wound drain removal 3 wk after surgery or a control group with progressive drain removal. The primary end point was overall early complications graded according to the modified Clavien-Dindo classification. Secondary endpoints were length of hospital stay and prognostic factors for early complications.
Of the 99 patients analyzed, ALND was performed in 58 patients and ILND in 41 patients. Overall, 62 patients (62.6%) developed early complications: 30 in the study group and 32 in the control group (P = 0.53). The confidence interval for the difference in proportions of patients without early complications in the two groups was -0.27 to 0.11 (P = 0.42), hence non-inferiority could be claimed. Length of hospital stay was 5 d in the study group compared to 6 in the control group (P < 0.01). ILND was associated with increased risk of early complications compared to ALND (75.6% versus 53.4%, P = 0.04).
Complete drain removal 3 wk after ALN and ILND in stage III melanoma patients did not increase the risk of early complications compared to progressive drain removal.
腋窝淋巴结清扫术（ALND）和腹股沟淋巴结清扫术（ILND）后并发症发生率高。本随机非劣效性研究旨在评估术后引流对 ALND 和 ILND 后早期并发症的影响。
2018 年至 2020 年间，对 104 例接受 ALND 或 ILND 手术的 III 期黑色素瘤患者进行随机分组，研究组术后 3 周完全拔除引流管，对照组逐渐拔除引流管。主要终点是根据改良 Clavien-Dindo 分级评估的总早期并发症。次要终点是住院时间和早期并发症的预测因素。
在 99 例分析的患者中，58 例接受 ALND，41 例接受 ILND。共有 62 例（62.6%）发生早期并发症：研究组 30 例，对照组 32 例（P=0.53）。两组无早期并发症患者比例的置信区间为-0.27 至 0.11（P=0.42），因此可以宣称非劣效性。研究组的住院时间为 5 天，对照组为 6 天（P<0.01）。与 ALND 相比，ILND 与早期并发症风险增加相关（75.6%比 53.4%，P=0.04）。
与逐渐拔除引流管相比，在 III 期黑色素瘤患者中，ALND 和 ILND 术后 3 周完全拔除引流管并不会增加早期并发症的风险。
