Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Department of Urology, Hanyang University Seoul Hospital, Hanyang University College of Medicine, Seoul, Korea.
BMC Cancer. 2024 Nov 27;24(1):1458. doi: 10.1186/s12885-024-13213-6.
To evaluate the clinical efficacy and safety of Monofix-PDO compared to V-Loc™ for tumor bed suturing during robotic-assisted laparoscopic partial nephrectomy (RAPN).
A randomized, controlled, multicenter, single-blinded trial was conducted across four tertiary institutions. Patients with T1-2 stage renal masses scheduled for RAPN were enrolled. The exclusion criteria included patients not deemed in need of bed suturing, those with a history of prior chemotherapy or immunotherapy, and those with severe systemic diseases or high bleeding tendencies. A total of 174 patients participated and were subjected to permuted block randomization (T1a vs. others), resulting in 88 patients in the V-Loc™ group and 86 in the Monofix-PDO group. The primary outcome was the resection bed suture time. The secondary outcomes were total suture use time, warm ischemia time, console time (for efficacy), estimated blood loss, hemoglobin change, and 90-day treatment-related adverse events (for safety). All patients were scheduled for follow-up visits for up to three months postoperatively.
The primary outcome, resection bed suture time, did not significantly differ between the V-Loc™ and Monofix-PDO groups (4.8 ± 2.6 vs. 4.5 ± 2.6 min, p = 0.531). Secondary outcomes, including total suture used time (5.3 ± 2.8 vs. 4.8 ± 2.6 min, p = 0.289) and warm ischemic time (15.6 ± 5.5 vs. 15.4 ± 5.4 min, p = 0.834), were comparable between the two groups. In terms of safety outcomes, changes in serum hemoglobin levels did not show significant differences on postoperative days 1, 3, and 14 (P = 0.537, 0.353, and 0.840, respectively). No device-related adverse events were observed during the 90-day follow-up period in either group.
Monofix-PDO demonstrated non-inferior to V-Loc in terms of both safety and efficacy in patients undergoing RAPN. This trial is registered on cris.nih.go.kr as KCT0006809 (Registration date: 02/19/2021).
评估 Monofix-PDO 与 V-Loc™ 在机器人辅助腹腔镜部分肾切除术 (RAPN) 肿瘤床缝合中的临床疗效和安全性。
在四家三级医疗机构进行了一项随机、对照、多中心、单盲试验。纳入 T1-2 期肾肿块患者，行 RAPN。排除标准包括不需要缝合床的患者、既往接受过化疗或免疫治疗的患者以及患有严重系统性疾病或高出血倾向的患者。共有 174 名患者参与，并进行了随机分组（T1a 与其他），其中 88 名患者入 V-Loc™ 组，86 名患者入 Monofix-PDO 组。主要结局为切除床缝合时间。次要结局包括总缝合时间、热缺血时间、控制台时间（疗效）、估计失血量、血红蛋白变化和 90 天治疗相关不良事件（安全性）。所有患者均安排术后随访 3 个月。
V-Loc™ 和 Monofix-PDO 组之间主要结局，即切除床缝合时间，无显著差异（4.8±2.6 与 4.5±2.6 min，p=0.531）。次要结局，包括总缝合时间（5.3±2.8 与 4.8±2.6 min，p=0.289）和热缺血时间（15.6±5.5 与 15.4±5.4 min，p=0.834），两组间无差异。在安全性结局方面，术后第 1、3 和 14 天血清血红蛋白水平的变化无显著差异（P=0.537、0.353 和 0.840）。两组患者在 90 天随访期间均未发生与器械相关的不良事件。
Monofix-PDO 在 RAPN 患者中具有与 V-Loc 相似的安全性和疗效。该试验在 cris.nih.go.kr 注册，注册号为 KCT0006809（注册日期：2021 年 2 月 19 日）。
