Health technology assessment of robotic surgery for rectal cancer in China: protocol for a nationally multicentre prospective cohort study.

BACKGROUND: Robot-assisted surgery (RAS) has been increasingly adopted for rectal cancer because of its technical advantages in the confined pelvic space, but its clinical and economic value relative to laparoscopic and open surgery remains uncertain. Existing health technology assessments have relied largely on small single-centre studies or modelling approaches, with limited evidence from low- and middle-income countries such as China, which has the world's largest population of patients with rectal cancer and rapid diffusion of RAS. METHODS AND ANALYSIS: We will conduct a prospective, multicentre, three-arm cohort study comparing RAS, laparoscopic and open low anterior resection for mid- and low-rectal adenocarcinoma. A total of 1200 patients (RAS 540, laparoscopy 540, open 120) will be recruited from 17 tertiary hospitals across geographically and socioeconomically diverse regions of China and followed for 36 months. Outcomes include surgical complications, oncologic efficacy (disease-free survival, overall survival, local recurrence), health-related quality of life (EQ-5D-5L), preoperative anxiety (PAS-7), surgeon comfort, number of personnel required for the surgery and comprehensive costs from a societal perspective (direct medical, direct non-medical and indirect). Cost-effectiveness and cost-utility analyses will be performed, with quality-adjusted life years (QALYs) derived from EQ-5D-5L. Analyses will use propensity score methods to control for confounding, supplemented by sensitivity and scenario analyses including a 36-month decision-analytic model. Subgroup analyses will explore heterogeneity by clinical, socioeconomic and institutional factors. ETHICS AND DISSEMINATION: The study protocol has been reviewed and approved by Peking University Health Science Center's Institutional Review Board (IRB00001052-24054). Written informed consent will be obtained from all participants. Findings will be reported according to best-practice guidelines for HTA and disseminated through peer-reviewed journals, international conferences and policy briefs. This study is designed to evaluate the clinical and economic outcomes of RAS compared with laparoscopic surgery, with additional descriptive analysis of open surgery in real-world practice.