The First Clinical Medical College of Nanchang University, Nanchang, 330000, China.
Department of Cardiology, The Third Hospital of Nanchang, Nanchang, 330000, China.
Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z.
Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes.
METHOD/DESIGN: Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system.
This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes.
ClinicalTrials.gov NCT04230772 . Registered on January 15, 2020.
为了减少腹部切口，已经引入了用于结直肠癌的自然腔道标本提取手术，这在微创手术中显示出了很大的发展潜力。我们正在进行这项随机对照试验，以评估机器人经自然腔道取标本手术（NOSES）是否在主要和次要结局方面不劣于传统的机器人辅助手术。
方法/设计：因此，将进行一项前瞻性、开放标签、随机对照、平行组、多中心和非劣效性试验，以讨论与传统机器人辅助手术相比，机器人自然腔道取标本手术的安全性和疗效。在这里，预计将招募 550 名参与者，以 80%的效能检测考虑到非劣效性边界为 10%时单侧显著性水平为 0.025 的差异。主要结局是手术并发症的发生率，将使用 Clavien-Dindo 系统进行分类。
本试验有望揭示机器人经自然腔道取标本手术是否不劣于传统的机器人辅助手术，这对于微创时代结直肠癌患者的机器人经自然腔道取标本手术的发展具有重要意义。此外，机器人经自然腔道取标本手术在主要和次要结局方面有望优于传统的机器人辅助手术。
ClinicalTrials.gov NCT04230772。于 2020 年 1 月 15 日注册。
