Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, China; Department of Thoracic Surgery, Xiamen Branch, Zhongshan Hospital, Fudan University, Shanghai, China.
J Thorac Cardiovasc Surg. 2024 Jul;168(1):290-298. doi: 10.1016/j.jtcvs.2023.10.040. Epub 2023 Oct 27.
This trial was to evaluate the efficacy of subxiphoid approach thoracoscopic thymectomy for postoperative pain control and length of hospital stay compared with a lateral intercostal approach thoracoscopic thymectomy.
This multicenter, open-label, randomized clinical superiority trial enrolled 101 eligible participants clinically diagnosed with Masaoka-Koga I-II thymoma between August 15, 2021, and February 15, 2022. Each enrolled participant was randomized and underwent subxiphoid approach thoracoscopic thymectomy or lateral intercostal approach thoracoscopic thymectomy. A per-protocol analysis for each coprimary outcome was performed in addition to the main intention-to-treat analysis.
In the analysis for the coprimary outcomes, the pain Visual Analog Scale score area under the curve at 0 to 7 days was lower in the subxiphoid approach thoracoscopic thymectomy group than in the lateral intercostal approach thoracoscopic thymectomy group (difference, -4.82; 98.3% CI, -8.84 to -0.80). However, there was no significant difference between the 2 groups in the length of hospital stay (difference, 0.318; 98.3% CI, -0.190 to 0.825) or cumulative opioid consumption after surgery (difference, -4.630; 98.3% CI, -9.530 to 0.272). All patients underwent complete resection, and there was no significant difference (7.84% vs 8.00%, P = 1.000) in the rate of complications between the 2 groups. No recurrence or death occurred in the postoperative 6 months.
This study found improved pain and similar length of hospital stay associated with the subxiphoid approach compared with the lateral intercostal approach in patients with suspected Masaoka-Koga I-II thymoma.
本试验旨在评估剑突下入路与侧肋间入路胸腔镜胸腺切除术在术后疼痛控制和住院时间方面的疗效，以评估其相对于侧肋间入路胸腔镜胸腺切除术的优势。
本多中心、开放标签、随机临床优效性试验纳入了 2021 年 8 月 15 日至 2022 年 2 月 15 日期间临床诊断为 Masaoka-Koga I-II 胸腺瘤的 101 名符合条件的参与者。每位入组的参与者均被随机分为剑突下入路胸腔镜胸腺切除术组或侧肋间入路胸腔镜胸腺切除术组。除了主要意向治疗分析外，还对每个主要结局进行了符合方案分析。
在对主要结局的分析中，剑突下入路胸腔镜胸腺切除术组在术后 0 至 7 天的疼痛视觉模拟量表评分曲线下面积低于侧肋间入路胸腔镜胸腺切除术组（差值为-4.82；98.3%CI，-8.84 至-0.80）。然而，2 组的住院时间（差值为 0.318；98.3%CI，-0.190 至 0.825）或术后累积阿片类药物消耗量（差值为-4.630；98.3%CI，-9.530 至 0.272）均无显著差异。所有患者均行完全切除术，2 组间并发症发生率无显著差异（7.84% vs 8.00%，P=1.000）。术后 6 个月内无复发或死亡发生。
本研究发现，在疑似 Masaoka-Koga I-II 胸腺瘤患者中，与侧肋间入路相比，剑突下入路可改善疼痛情况，并具有相似的住院时间。
