Robotic and Laparoscopic Gynaecological Surgery: A Prospective Multi-Centre Observational Cohort Study and Economic Evaluation in England.

OBJECTIVE: To compare the health-related quality of life and cost-effectiveness of robot-assisted laparoscopic surgery (RALS) versus conventional 'straight stick' laparoscopic surgery (CLS) in women undergoing hysterectomy as part of their treatment for either suspected or proven gynaecological malignancy.

DESIGN: Multicentre prospective observational cohort study.

SETTING: Patients aged 16+ undergoing hysterectomy as part of their treatment for gynaecological malignancy at 12 National Health Service (NHS) cancer units and centres in England between August 2017 and February 2020.

PARTICIPANTS: 275 patients recruited with 159 RALS, 73 CLS eligible for analysis.

OUTCOME MEASURES: Primary outcome was the European Organisation for Research and Treatment of Cancer Quality of Life measure (EORTC). Secondary outcomes included EuroQol-5 Dimension (EQ-5D-5L) utility, 6-minute walk test (6MWT), NHS costs using pounds sterling (£) 2018-2019 prices and cost-effectiveness. The cost-effectiveness evaluation compared EQ-5D-5L quality adjusted life years and costs between RALS and CLS.

RESULTS: No difference identified between RALS and CLS for EORTC, EQ-5D-5L utility and 6MWT. RALS had unadjusted mean cost difference of £556 (95% CI -£314 to £1315) versus CLS and mean quality adjusted life year (QALY) difference of 0.0024 (95% CI -0.00051 to 0.0057), non-parametric incremental cost-effectiveness ratio of £231 667per QALY. For the adjusted cost-effectiveness analysis, RALS dominated CLS with a mean cost difference of -£188 (95% CI -£1321 to £827) and QALY difference of 0.0024 (95% CI -0.0008 to 0.0057).

CONCLUSIONS: Findings suggest that RALS versus CLS in women undergoing hysterectomy (after adjusting for differences in morbidity) is cost-effective with lower costs and QALYs. Results are highly sensitive to the usage of robotic hardware with higher usage increasing the probability of cost-effectiveness. Non-inferiority randomised controlled trial would be of benefit to decision-makers to provide further evidence on the cost-effectiveness of RALS versus CLS but may not be practical due to surgical preferences of surgeons and the extensive roll out of RALS.