Health Technology Assessment of Robot-Assisted Versus Laparoscopic Low Anterior Resection for Middle and Low Rectal Cancer: A Prospective Cohort Study

Speaker(s)

Hu X1, Wu Z2, Cai Z3, Lyu B2, Liu GG2
1Institute for Global Health and Development, Peking University, Beijing, 11, China, 2Institute for Global Health and Development, Peking University, Beijing, Beijing, China, 3Colorectal Surgery, the Sixth Affiliated Hospital of Sun Yat-sen University; Guangdong Provincial Institute of Gastroenterology; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, GuangDong, China

Presentation Documents

OBJECTIVES: Colorectal cancer is s among the top five malignant tumors in both incidence and mortality in China. Robot-assisted surgery (RAS) may have clinical advantages but is more costly than laparoscopic surgery. There is a lack of health economic evaluation of RAS versus laparoscopic surgery among rectal cancer patients using real-world data. To evaluate the clinical outcomes and health economic value of RAS versus laparoscopic or open surgery in patients with mid-low rectal cancer undergoing low anterior resection.

METHODS: This is a nationwide, multicenter, prospective cohort study in China. The study will enroll patients aged 18-75 years old and undergone radical anterior resection for mid-low rectal cancer (RAS, laparoscopic, or open surgery). Patients will be followed for 3 years, with follow-up every 3 months during the first year and every 6 months in 2nd and 3rd year. The study sites include 16 top-tier hospitals located in different geographical regions of China. The study will enroll 1200 patients, with 540 in RAS and laparoscopic group and 120 in open surgery group. Demographic, socioeconomic status, lab tests, and oncologic characteristic will be collected. The study will collect clinical outcomes, quality of life (EQ-5D-5L), preoperative anxiety, surgeon characteristics, and surgeon comfort level after operation. In addition, the study will collect information about direct medical costs, direct non-medical costs, and indirect costs. The health benefits and costs and the incremental cost-effectiveness ratio and incremental cost-utility ratio of RAS compared to laparoscopic surgery and open surgery will be compared.

RESULTS: From a societal perspective, the study will be the largest real-world health technology assessment study globally to compare RAS versus laparoscopic and open surgery in patients undergoing low anterior resection for middle and low rectal cancer.

CONCLUSIONS: The study will provide high-quality data for formulating relevant pricing and reimbursement policies.

Code

HTA80

Topic

Economic Evaluation, Patient-Centered Research, Study Approaches

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis, Patient-reported Outcomes & Quality of Life Outcomes, Prospective Observational Studies, Work & Home Productivity - Indirect Costs

Disease

Oncology, Surgery