Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials

Fangfang Zheng¹  Penghui He²  Dongning Liu²  Weiquan Zhu²  Rui Luo³  Haobo Zhang³ 

[1] Department of Cardiology, The Third Hospital of Nanchang, 330000, Nanchang, China;Department of General Surgery, The First Affiliated Hospital of Nanchang University, 330000, Nanchang, China;The First Clinical Medical College of Nanchang University, 330000, Nanchang, China;

关键词: Natural orifice extraction surgery;    Randomized controlled trial;    Robotic surgery;    Colorectal cancer;   

DOI  :  10.1186/s13063-021-05077-z

来源: Springer

【 摘 要 】

BackgroundNatural 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/designAccordingly, 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.DiscussionThis 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.Trial registrationClinicalTrials.govNCT04230772. Registered on January 15, 2020.

【 授权许可】

CC BY